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burns 34 (2008) 929–934



                                             available at www.sciencedirect.com




                                    journal homepage: www.elsevier.com/locate/burns



Patient controlled sedation using a standard protocol for
dressing changes in burns: Patients’ preference, procedural
details and a preliminary safety evaluation§
Andreas Nilsson a,*, Ingrid Steinvall b, Zoltan Bak b,c, Folke Sjoberg b,c,d
                                                                 ¨
a
  Department of Anesthesiology and Intensive Care, Division of Perioperative Medicine, Linkoping University Hospital,
                                                                                           ¨
581 85 Linkoping, Sweden
             ¨
b
  The Burn Unit, Department of Hand and Plastic Surgery, Linkoping University Hospital, 581 85 Linkoping, Sweden
                                                               ¨                                     ¨
c
  Department of Intensive Care, Linkoping University Hospital, 581 85 Linkoping, Sweden
                                     ¨                                      ¨
d
  Faculty of Health Sciences, Department of Biomedicine and Surgery, Linkoping University Hospital, 581 85 Linkoping, Sweden
                                                                          ¨                                    ¨



article info                                 abstract

Article history:                             Background: Patient controlled sedation (PCS) enables patients to titrate doses of drugs by
Accepted 10 April 2008                       themselves during different procedures involving pain or discomfort.
                                             Methods: We studied it in a prospective crossover design using a fixed protocol without
Keywords:                                    lockout time to examine it as an alternative method of sedation for changing dressings in
Alfentanil                                   burned patients. Eleven patients with >10% total burn surface area (TBSA) had their
Anesthesia                                   dressings changed, starting with sedation by an anaesthetist (ACS). The second dressing
Burns                                        change was done with PCS (propofol/alfentanil) and the third time the patients had to
Propofol                                     choose ACS or PCS. During the procedures, data on cardiopulmonary variables, sedation
Patient controlled sedation                  (bispectral index), pain intensity (VAS), procedural details, doses of drugs, and patients’
Sedation                                     preferences were collected to compare the two sedation techniques.
                                             Results: The study data indicated that wound care in burned patients is feasible with a
                                             standardized PCS protocol. The patients preferred PCS to ACS on the basis of self-control,
                                             and because they had less discomfort during the recovery period. Wound care was also
                                             considered adequate by the staff during PCS. No respiratory (respiratory rate/transcuta-
                                             neous PCO2) or cardiovascular (heart rate/blood pressure) adverse events were recorded at
                                             any time during any of the PCS procedures. The doses of propofol and alfentanil and BIS
                                             index decrease were less during PCS than ACS. Procedural pain was higher during PCS but
                                             lower after the procedure.
                                             Conclusion: We suggest that PCS using a standard protocol is an interesting alternative to
                                             anaesthetist-provided sedation during dressing changes. It seems effective, saves
                                             resources, is safe, and at same time is preferred by the patients. The strength of these
                                             conclusions is, however, hampered by the small size of this investigation and therefore
                                             further studies are warranted.
                                                                                       # 2008 Elsevier Ltd and ISBI. All rights reserved.




    §                                                                                                               ¨
   The study was performed at the Burn Unit, Department of Hand and Plastic Surgery, Linkoping University Hospital, Ostergotland
                                                                                         ¨                                ¨
County Council.
 * Corresponding author. Tel.: +46 13 22 1834; fax: +46 13 22 2836.
   E-mail address: andreas.nilsson@lio.se (A. Nilsson).
0305-4179/$34.00 # 2008 Elsevier Ltd and ISBI. All rights reserved.
doi:10.1016/j.burns.2008.04.002
930                                                  burns 34 (2008) 929–934



1.      Introduction                                                enrolled in a prospective exploratory study at the National
                                                                    Burn Centre at Linkoping University Hospital, Linkoping,
                                                                                           ¨                                  ¨
Patients with severe burns have severe pain and anxiety,            Sweden.
which have both psychological and physical effects for the             Inclusion criteria were: need for analgesia and sedation for
recovery process [1]. Pain for these patients is elicited not       at least two consecutive dressing changes. Patients with
only from the trauma event, but is also the result of               injures of more than 10% or more than 5% full thickness was
repeated procedures, dressing changes and physiotherapy.            asked to participate. Exclusion criteria were ASA III–V, burned
These procedures are repeated, and often lead to appreci-           hands (because of difficulties in using the PCS device) or
able pain, and they emphasise the need for advanced                 difficulties in communication or understanding of the proce-
strategies for the treatment of pain [2]. Morphine, fentanyl,       dure. Four patients entered the study but did not fulfil the
and alfentanil are commonly used opioids that provide               protocol because only one or two dressing changes were
continuous, analgesia during and after the operation and            needed that required analgesia and sedation.
the intravenous route is often preferred for rapid pain                The study was designed as a single-centre, single-case,
control. Self-titration of morphine (patient controlled             crossover, controlled study. Patients were their own control
analgesia; PCA) has been suggested as an important                  group, because they started with dressing changes under
technique to meet the increasing and high requirement               sedation by an anaesthetist (ACS, FS or ZB; anesthesiologists
for opioids [3]. Successful pain management requires that           with 10 years experience of burn care) using routine sedating
pain is regularly assessed and its intensity evaluated as, for      techniques. While the patient breathed oxygen and air,
example by a visual analogical scale (VAS), and adequate            sedation and analgesia were accomplished with intermittent,
pain relief must be provided accordingly [4]. Wound care            intravenous propofol (Propofol-1Lipuro 10 mg/ml, Braun) and
and dressing changes are associated not only with pain, but         fentanyl (Fentanyl1 0.05 mg/ml, Braun). The second dressing
with factors that are also known to affect the experience of        change was done using PCS as described below. At the third
pain such as anxiety and loss of self-control. The ther-            dressing change the patients were asked to choose one of the
apeutic challenge is to find methods that control pain and           two techniques.
relieve anxiety and at the same time avoid over-sedation               During the sedation procedures a protocol was used to
and a delayed recovery [1].                                         collect cardiopulmonary data (heart rate, non-invasive blood
    Patient controlled sedation (PCS) has received increasing       pressure, saturation, and respiratory rate). Transcutaneous
interest when it has been used to improve the conditions of         PCO2 were collected using TCM3—TINA (Radiometer, Copen-
patients having painful or unpleasant procedures such as            hagen, Denmark). Intensity of pain was assessed using a 11-
lithotripsy, colonoscopy, or dental procedures [5–7]. It is         point visual analogue scale (VAS) when patients were able to
important also to others that the patient controlled sedation       answer during the procedure, after finishing the dressing
technique has been used in these settings (lithotripsy,             changes, and 10 min later. Complications were recorded,
dental, colonoscopy) without anesthesia-trained personnel.          whether it was possible to treat the wounds adequately (yes
Presently, in clinical practice at our hospital, lithotripsy is     or no), and the duration of treatment. The bispectral (BIS)
done using a propofol-based PCS technique without                   index was monitored using the A-2000 BISTM system (Aspect
anesthesia-trained personnel. The procedure is based on             Medical Systems, Natick, MA, USA). The recording of all these
European Guidelines for sedation and/or analgesia by non-           variables started before the onset of sedation and every 3 min
anaesthesiology doctors [8]. In patients with burns we are          during the procedure, and up to 30 min afterwards. If a lower
aware of only one dose-finding study that attempted to use           BIS index appeared on the display between measurement
it as an alternative to traditional ways of giving analgesics       points, the lowest observed index was recorded. Within 2 h of
and sedatives [9].                                                  completion of the dressing change, each patient was asked
    The present study was designed to compare PCS, based on a       about how they experienced the sedation and the awakening
standard protocol, with routine sedation provided by anaes-         from it.
thetists, to assess the feasibility of PCS for adequate dressing
changes, and also to assess patients’ preferences. Close            2.2.    Patient controlled sedation
surveillance of respiratory (respiratory rate/transcutaneously
assessed PCO2) and cardiovascular (heart rate/mean arterial         One hour before the dressing change all patients were given
pressure) data were measured as an estimate of safety, as the       their regular daytime analgesics. These comprised: acetami-
aim is to, in the future and after further refinement, to            nophen (Panodil1 1 g, GlaxoSmithKline Healthcare) and a
implement this strategy in the care of patients with burns          long-acting opioid, Oxycodone (Oxycontin1 between 5 and
without using specifically trained anaesthesia personnel.            40 mg). Before the start of the procedure or the anticipated
                                                                    pain the patients were asked to give sedation or analgesia by
                                                                    the PCS device whenever they felt pain or anxiety. Anticipated
2.      Patients and methods                                        painful events were predicted during the procedure and
                                                                    conveyed to the patients so that they could prepare them-
2.1.    Study overview                                              selves by giving analgesia and sedation.
                                                                       Propofol, 20 mg/ml (Propofol-1Lipuro 20 mg/ml, Braun,
After approval from the local ethics committee and informed         Sweden) and alfentanil 0.5 mg/ml (Rapifen1 0.05 mg/ml,
consent of the patients, 11 patients with ASA I or II scores with   Janssen-Cilag, Sweden) were mixed to 14.8 mg/ml of propofol
burns exceeding 10% total burn surface area (TBSA) were             and 0.13 mg/ml of alfentanil in the final solution. A bag
burns 34 (2008) 929–934                                                               931


 Table 1 – Details of the patients
 Patient        TBSA            Age                              ACS                                                       PCS

                                               Time            Propofol            Morphine            Time          Propofol          Morphine

 1               15             74              64              325                    10               74               153               10
 2               35             32              69              500                    40               85               282               18
 3               12             51              91              480                    20               52               140                9
 4               12             82              33              170                    10               50                89                5
 5               15             67              81              234                    10               62               195               12
 6               18             23             130              632                    25               60               271               17
 7               16             77              82              320                    15              113               191               12
 8               10             68              65              395                    15               50               164               10
 9                8             62              44              412                    15               56               102                6
 10              19             59              56              490                    20               78               173               11
 11              20             38              47              385                    25               63               369               23

 Mean            16.4           57.5            69.3*           394.8**                18.6***          67.5*            193.5**           12.1***
 S.D.             7.2           19.3            26.7            130.7                   9.0             19.0              83.5              5.3

 ACS = anaesthetist controlled sedation; PCS = patient controlled sedation.
 The doses of propofol and alfentanil were given during ACS and the first PCS.
 Values as mean and standard deviation (S.D.). Doses in milligrams and time in min. Total burned surface area (TBSA).
 *P = 0.859 (NS); **P = 0.003; ***P = 0.007. Statistical differences are shown between propofol and morphine.




containing the mixture was connected to an electromecha-                    3.           Results
nical pump (Graseby 9300 PCS, Graseby Medical Ltd., Watford,
UK). Each time the button was pushed, the patient received                  3.1.         Details of patients (Table 1)
0.3 ml of the mixture, equivalent to 4.44 mg propofol and
0.039 mg alfentanil. No lockout period was used, which                      All the patients started the study with ACS followed by at least
resulted in a quantity of 22.2 mg propofol and 0.20 mg                      two PCS. Ten of the 11 patients preferred to continue dressing
alfentanil possible to give in 1 min.                                       changes using PCS after the first ACS and PCS. One patient was
   For comparison and calculations the analgesic doses that of              indifferent to the techniques but finally chose PCS.
alfentanil was multiplied by a factor of 7, resulting in
equipotent doses of morphine. Doses of fentanyl were multi-                 3.2.     Cardiopulmonary and surveillance data
plied by the factor of 100 [10].                                            (Fig. 1 and Table 2)

2.3.    Data analysis and statistics                                        Differences were found for SpO2, BIS, and transcutaneous
                                                                            PCO2, between ACS and PCS. PCS gave higher mean SpO2
Data are presented as either mean (S.D.) or median (inter-                  concentrations, but lower PCO2, and less sedation according to
quartile range). For the statistical analysis we used Statis-               BIS monitoring.
tica1 Version 6.1 (Stat Soft, Inc., Tulsa, USA). To assess                     During ACS there was a slight decrease in saturation (<90%)
differences between groups we used the Wilcoxon Matched                     in two cases, the lowest respiratory rate was 8, and a lowest
Pairs Test. Changes over time in surveillance data between                  BIS index was 48. Blood pressure (MAP) was reduced during
ACS and all PCS procedures were evaluated by repeated                       both techniques, the lowest values being between 50 and 68%
measures ANOVA. Values of P < 0.05 were accepted as                         of baseline. Equivalent data during PCS showed no saturation
significant.                                                                 value lower than 94% and no respiratory rate less than 10. The



 Table 2 – Cardiopulmonary data and sedation data during ACS and PCS
                                         ACS                                                PCS                      Statistical differences (P)

                          Mean (S.D.)            Min–Max               Mean (S.D.)                Min–Max

 SpO2, %                    98 (3)                    84–100              99 (2)                    94–100                         0.032
 RR                         14 (2)                     8–17               16 (5)                    10–30                          0.707
 PtcCO2 (kPa)                5.3 (0.4)               4.5–6.2               5.2 (0.5)               4.0–6.2                         0.004
 BIS index                  84 (11)                   48–99               93 (5)                    67–99                          0.027
 HR                         80 (11)                   56–118              80 (11)                   65–102                         0.686
 MAP (mmHg)                 70 (15)                   33–110              83 (11)                   58–115                         0.663

 ACS = anaesthetist controlled sedation; PCS = patient controlled sedation.
 Values as mean and standard deviation (S.D.).
 Lowest and highest values recorded are presented as Min and Max.
 RR = respiratory rate, PtcCO2 = transcutaneous carbon dioxide, BIS index = bispectral index, HR = heart rate and MAP = mean arterial pressure.
932                                                burns 34 (2008) 929–934




                                                                  Fig. 3 – Capacity of the pump in comparison with the
                                                                  patients with the highest demands. The doses are
                                                                  presented accumulated from start to the last received
                                                                  dose. Time (min) is from start.

Fig. 1 – BIS index during ACS (sedation controlled by
anaesthetist) and patient controlled sedation (PCS).
                                                                  given the doses. The capacity of the pump in relation to the
                                                                  patients with high dose demands is shown in Fig. 3.

lowest MAP recordings were within 60 and 96% of baseline.         3.4.    Procedure rating by personnel
Reduction in the BIS index also occurred during PCS with six
recordings less than 80.                                          After dressing changes, wound care personnel said that in all
                                                                  cases, during ACS and PCS, sedation was adequate and, wound
3.3.    Amount of drug given (Table 1 and Fig. 2)                 care conditions was good. Two surgeons indicated, however,
                                                                  that cleansing of the wounds could have been better on two
During PCS all patient requested lower doses of propofol and      occasions during PCS.
morphine (193.5 (83.5) and 12.1 (5.3) mg mean (S.D.)) than they
were given by the anaesthetist during ACS (394.8 (130.7) and      3.5.    Pain ratings (Table 3)
18.6 (9.0) mg). There was no difference in duration of
procedure between PCS (67.5 (19.0) min) and ACS (69.3             The highest mean (S.D.) pain ratings recorded, during wound
(26.7) min).                                                      treatment were greater for PCS (4.9 (2.4)) than for ACS (1.5
   During PCS procedures, four patients had a third or less of    (1,0)). Immediately and 10 min after dressing changes there
the required doses. The remaining seven patients had more         were no differences.
than 40% of required doses. Two of the four patients given less
than a third of the doses given were not satisfied with the
capacity of the pump, although PCS overall was preferred. The     4.      Discussion
nine remaining patients were satisfied with how they were
                                                                  The new finding of this study is that PCS, using a standard
                                                                  technique with a fixed protocol comprising the drugs propofol
                                                                  and alfentanil, can be used successfully as an alternative to
                                                                  ACS for wound care in burned patients. When patients chose
                                                                  between PCS and ACS, they chose PCS and truly preferred
                                                                  being in charge of their sedation instead of relying on
                                                                  somebody else. Although comparable data are lacking for
                                                                  burns, previous studies indicated a preference for PCS during
                                                                  other painful or unpleasant procedures [6,7]. A sense of
                                                                  control, together with a more rapid and less unpleasant
                                                                  recovery, together with the remaining possibility of deeper
                                                                  sedation if necessary were reasons given for the choice of PCS
                                                                  in the present study.

                                                                  4.1.    The procedure and pain

                                                                  With a patient who can communicate, those who are caring
Fig. 2 – Doses of propofol given by anaesthetist (ACS)            for the wounds informed them if unpleasant or painful
compared with the doses requested by the patients (PCS)           moments were to be expected, which gives them time to give
during the first PCS.                                             the sedation and analgesia properly as described previously
burns 34 (2008) 929–934                                                        933


 Table 3 – Intensity of pain evaluated with visual analogue scale (VAS)
 Patient                                      ACS                                                            PCS

                   VAS max            VAS min 0             VAS min 10             VAS max            VAS min 0            VAS min 10

 1                   2                    4                    4                      5                  3                     0
 2                   0                    7                    3                      8                  5                     3
 3                   0                    4                    1                      4                  1                     1
 4                   0                    0                    0                      1                  0                     0
 5                   2                    0                    0                      3                  0                     0
 6                   2                    3                    1                      6                  1                     1
 7                   2                    0                    0                      3                  0                     0
 8                   2                    6                    3                      8                  4                     2
 9                   3                    2                    2                      5                  4                     2
 10                  2                    2                    2                      3                  3                     1
 11                  1                    1                    0                      8                  2                     0

 Mean                1.45*                2.64**               1.45***                4.91*              2.09**                0.91***
 S.D.                1.04                 2.42                 1.44                   2.39               1.81                  1.04

 ACS = anaesthetist controlled sedation; PCS = patient controlled sedation.
 Values as mean and standard deviation (S.D.).
 Maximum pain score (VAS max in table) represent highest pain experienced during changing dressings and VAS min 0 is the pain intensity
 immediate after treatment. 10 min after dressing change pain intensity was again asked for (VAS min 10).
 *P = 0.003; **P = 0.234; ***P = 0.109.




[6]. As this was the first series of PCS in this unit, the procedure      present sedation. PCS itself is a factor in the satisfaction
might be refined further as personnel get more acquainted                 among patients having cataract surgery, whether they did use
with the technique. We noticed that although special                     the pump with propofol or not [11] which in some way may
emphasis was placed on preparing the patients and predicting             contribute to acceptance of the pain recorded in our study.
painful events, this was at times missed and may together
with the sometimes impatient behaviour of the personnel                  4.2.    Safety
explain the intermittently high VAS scores recorded during
care of the wound and PCS. Astonishingly, despite the high               Despite the fact that this study used propofol and alfentanil in
VAS reported, it did not seem to affect the patients overall             concentrations higher than evaluated previously [6,7,11,12]
judgement of the technique. To optimise the procedure,                   and a device without a lock out time, PCS was accomplished
therefore, further training may lead to less pain without the            without extreme values in cardiopulmonary or BIS data. The
need to change the doses of any drugs. The finding that the               patients were monitored closely and were given supplemen-
length of the procedures done by ACS and PCS did not differ              tary oxygen and it is therefore unlikely that any adverse
also suggests that PCS was adequate.                                     reaction has been overlooked. In all, we recorded no single
    We made an interesting, new discovery during this trial. In          value that indicated compromise of breathing or circulation.
all patients verbal complaints of pain (with corresponding               The fact that the corresponding decrease in the BIS index was
higher VAS scores) were not always accompanied by pressure               also minor supports this further. One must, however, be
on the button to release the drug. There seemed to be                    cautious about the strength of this conclusion, as the number
cognitive dysfunction with the present drugs and protocol                of patients was small.
where, despite patients verbally complaining of pain, they                  The smaller amounts of analgesic and sedative used in the
were unable to process that into the action of providing                 study is probably the explanation for there being fewer
themselves with more of the drug. No extra doses were given              symptoms of sedation after the procedure, which also
by any bystander.                                                        explains the lack of effects on circulation and breathing.
    The high scores for pain recorded, and which seem
unreasonably high, argues for more analgesic. This could                 4.3.    Sedation effects
theoretically be accomplished either by increasing the dose of
alfentanil given by PCS or by the supplementation of a longer-           BIS monitoring was used to acquire objective data about the
acting analgesic at the start of the procedure. This must to be          state of sedation, instead of using sedation scales, which often
examined further. We must point out that not a single patient            involve some interactivity with the patient [7]. BIS indexes
reached the maximum capacity of the pump; however, at the                were collected during the procedure with no major distur-
same time it is difficult to give the maximum dose as there is a          bances. The position of the patient’s head must be still and
hidden lockout time during which the pump delivers a dose                controlled as the BIS monitor detects muscular movement,
already requested. An alternative is to increase the volume of           and the signal quality may then be affected. We had few such
alfentanil, but that will only be achieved with less propofol,           problems. BIS monitoring has been evaluated with propofol
which will result in reduced sedation (given that the Graseby            sedation and is a good predictor of the level of sedation [13].
pump as presently sold commercially delivers only a fixed                 However, there is a lag time between decreasing values and
maximum volume). As far as we know patients appreciate the               the outcome of an observer’s assessment [14]. As the purpose
934                                                burns 34 (2008) 929–934



was not to delineate minor changes but rather to establish        work. This study is performed on clinical basis of the Burn
sedation levels, mainly for the group using PCS, we do not        Unit, with no external influence.
think that this has an impact on the interpretation of our
results. As for PCS, few values were recorded below 80%,
                                                                  references
which is similar to the findings made by Coimbra et al. [9]. The
lowest values were present during ACS, which has been a
common finding by other authors who compared ASC and PCS
                                                                                         ´
                                                                   [1] Latarjet J, Choiniere M. Pain in burn patients. Burns
such as in, colonoscopy [6]. In that study the corresponding
                                                                       1995;21:344–8.
figures were 58 (ACS) and 71 (ACS), respectively.
                                                                   [2] Ashburn M. Burn pain: the management of procedure-
                                                                       related pain. J Burn Care Rehabil 1995;16:365–71.
4.4.    Other issues                                               [3] MacLennan N, Heimbach D, Cullen B. Anesthesia for major
                                                                       thermal injury. Anesthesiology 1998;89:749–70.
There are some other issues of importance that should be           [4] Jonsson CE, Holmsten A, Dahlstrom L, Jonsson K.
                                                                                                          ¨
discussed.                                                             Background pain in burn patients: routine measurement
                                                                       and recording of pain intensity in a burn unit. Burns
   Firstly, when we compare PCS and ACS we must
                                                                       1998;24:448–54.
emphasise that the present standard in Sweden is to use
                                                                   [5] Alhashemi JA, Kaki AM. Anesthesiologist-controlled versus
ACS for patients with major burns. We know that inter-                 patient-controlled propofol sedation for shockwave
nationally many units do their dressings with no anaesthetist          lithotripsy. Can J Anaesth 2006;53:449–55.
support. We think that this argues for PCS as an interesting       [6] Roseveare C, Seavell C, Patel P, Crisswell J, Kimble J, Jones C,
alternative to the present procedure, in which anaesthetic             et al. Patient-controlled sedation and analgesia, using
personnel are required, and it also may explain why patients           propofol and alfentanil, during colonoscopy: a prospective
                                                                       randomized controlled trial. Endoscopy 1998;30:768–73.
accept the procedure to such a large extent with not much
                                                                   [7] Oei-Lim VLB, Kalkman CJ, Makkes PC, Ooms WG. Patient-
sedation. The PCS technique would certainly reduce con-                controlled versus anesthesiologist-controlled conscious
sumption of resource.                                                  sedation with propofol for dental treatment in anxious
   For PCS in the present study we used a push-button device,          patients. Anesth Analg 1998;86:967–72.
which made it difficult to recruit patients with burnt hands.       [8] Knape JTA, Adriaensen H, van Aken H, Blunnie WP,
These are common among our patients [15]. Several candi-               Carlsson C, Dupont M, et al. Guidelines for sedation and/or
dates for the investigation were also excluded for this reason.        analgesia by non-anaesthesiology doctors. Eur J
                                                                       Anaesthesiol 2007;24:563–7.
There are, however, other techniques that could be tried for
                                                                                           ´
                                                                   [9] Coimbra C, Choiniere M, Hemmerling TM. Patient-
these patients.                                                        controlled sedation using propofol for dressing changes in
   The study was not blind; unfortunately this is not possible         burn patients: a dose-finding study. Anesth Analg
with these techniques. We claimed that we used ‘‘true PCS’’, as        2003;97:839–42.
no ‘‘lockout’’ time was used. This is not completely true as in   [10] Wood M, Alastair JJ. Drugs and anesthesia: pharmacology
practice there is a lockout time when the pump is giving the           for anesthesiologist, 2nd ed., Williams & Williams; 1990.
                                                                  [11] Herrick IA, Gelb AW, Nichols B, Kirkby T. Patient-controlled
actual dose. This time is in the range of 15 s, and may explain
                                                                       propofol sedation for elderly patients: safety and patient
the discrepancy between the doses requested and the doses
                                                                       attitude toward control. Can J Anaesth 1996;43:1014–8.
delivered.                                                        [12] Sim KM, Hwang NC, Chan YW, Sean CS. Use of patient-
   In conclusion, PCS as presented in this study using a fixed          controlled analgesia with alfentanil for burns dressing
protocol appears an interesting alternative to ACS for dressing        procedures: a preliminary report of five patients. Burns
changes in serious burns. The patients chose PCS, and                  1996;22:238–41.
preferred it because they had better control and less sedation    [13] Schraag S, Bothner U, Gajraj R, Kenny GN, Georgieff M. The
                                                                       performance of electroencephalogram bispectral index and
after the procedure despite having less sedation during it and
                                                                       auditory evoked potential index to predict loss of
more pain.                                                             consciousness during propofol infusion. Anesth Analg
                                                                       1999;89:1311–5.
                                                                  [14] Chen SC, Rex DK. An initial investigation of bispectral
Conflict of interest                                                    monitoring as an adjunct to nurse-administered propofol
                                                                       sedation for colonoscopy. Am J Gastroenterol 2004;99:1081–6.
None of the authors have any financial or personal relation-       [15] Smith MA, Munster AM, Spence RJ. Burns of the hand and
                                                                       upper limb—a review. Burns 1998;24:493–505.
ship with people or organizations that could influence this

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Anestesia 2

  • 1. burns 34 (2008) 929–934 available at www.sciencedirect.com journal homepage: www.elsevier.com/locate/burns Patient controlled sedation using a standard protocol for dressing changes in burns: Patients’ preference, procedural details and a preliminary safety evaluation§ Andreas Nilsson a,*, Ingrid Steinvall b, Zoltan Bak b,c, Folke Sjoberg b,c,d ¨ a Department of Anesthesiology and Intensive Care, Division of Perioperative Medicine, Linkoping University Hospital, ¨ 581 85 Linkoping, Sweden ¨ b The Burn Unit, Department of Hand and Plastic Surgery, Linkoping University Hospital, 581 85 Linkoping, Sweden ¨ ¨ c Department of Intensive Care, Linkoping University Hospital, 581 85 Linkoping, Sweden ¨ ¨ d Faculty of Health Sciences, Department of Biomedicine and Surgery, Linkoping University Hospital, 581 85 Linkoping, Sweden ¨ ¨ article info abstract Article history: Background: Patient controlled sedation (PCS) enables patients to titrate doses of drugs by Accepted 10 April 2008 themselves during different procedures involving pain or discomfort. Methods: We studied it in a prospective crossover design using a fixed protocol without Keywords: lockout time to examine it as an alternative method of sedation for changing dressings in Alfentanil burned patients. Eleven patients with >10% total burn surface area (TBSA) had their Anesthesia dressings changed, starting with sedation by an anaesthetist (ACS). The second dressing Burns change was done with PCS (propofol/alfentanil) and the third time the patients had to Propofol choose ACS or PCS. During the procedures, data on cardiopulmonary variables, sedation Patient controlled sedation (bispectral index), pain intensity (VAS), procedural details, doses of drugs, and patients’ Sedation preferences were collected to compare the two sedation techniques. Results: The study data indicated that wound care in burned patients is feasible with a standardized PCS protocol. The patients preferred PCS to ACS on the basis of self-control, and because they had less discomfort during the recovery period. Wound care was also considered adequate by the staff during PCS. No respiratory (respiratory rate/transcuta- neous PCO2) or cardiovascular (heart rate/blood pressure) adverse events were recorded at any time during any of the PCS procedures. The doses of propofol and alfentanil and BIS index decrease were less during PCS than ACS. Procedural pain was higher during PCS but lower after the procedure. Conclusion: We suggest that PCS using a standard protocol is an interesting alternative to anaesthetist-provided sedation during dressing changes. It seems effective, saves resources, is safe, and at same time is preferred by the patients. The strength of these conclusions is, however, hampered by the small size of this investigation and therefore further studies are warranted. # 2008 Elsevier Ltd and ISBI. All rights reserved. § ¨ The study was performed at the Burn Unit, Department of Hand and Plastic Surgery, Linkoping University Hospital, Ostergotland ¨ ¨ County Council. * Corresponding author. Tel.: +46 13 22 1834; fax: +46 13 22 2836. E-mail address: andreas.nilsson@lio.se (A. Nilsson). 0305-4179/$34.00 # 2008 Elsevier Ltd and ISBI. All rights reserved. doi:10.1016/j.burns.2008.04.002
  • 2. 930 burns 34 (2008) 929–934 1. Introduction enrolled in a prospective exploratory study at the National Burn Centre at Linkoping University Hospital, Linkoping, ¨ ¨ Patients with severe burns have severe pain and anxiety, Sweden. which have both psychological and physical effects for the Inclusion criteria were: need for analgesia and sedation for recovery process [1]. Pain for these patients is elicited not at least two consecutive dressing changes. Patients with only from the trauma event, but is also the result of injures of more than 10% or more than 5% full thickness was repeated procedures, dressing changes and physiotherapy. asked to participate. Exclusion criteria were ASA III–V, burned These procedures are repeated, and often lead to appreci- hands (because of difficulties in using the PCS device) or able pain, and they emphasise the need for advanced difficulties in communication or understanding of the proce- strategies for the treatment of pain [2]. Morphine, fentanyl, dure. Four patients entered the study but did not fulfil the and alfentanil are commonly used opioids that provide protocol because only one or two dressing changes were continuous, analgesia during and after the operation and needed that required analgesia and sedation. the intravenous route is often preferred for rapid pain The study was designed as a single-centre, single-case, control. Self-titration of morphine (patient controlled crossover, controlled study. Patients were their own control analgesia; PCA) has been suggested as an important group, because they started with dressing changes under technique to meet the increasing and high requirement sedation by an anaesthetist (ACS, FS or ZB; anesthesiologists for opioids [3]. Successful pain management requires that with 10 years experience of burn care) using routine sedating pain is regularly assessed and its intensity evaluated as, for techniques. While the patient breathed oxygen and air, example by a visual analogical scale (VAS), and adequate sedation and analgesia were accomplished with intermittent, pain relief must be provided accordingly [4]. Wound care intravenous propofol (Propofol-1Lipuro 10 mg/ml, Braun) and and dressing changes are associated not only with pain, but fentanyl (Fentanyl1 0.05 mg/ml, Braun). The second dressing with factors that are also known to affect the experience of change was done using PCS as described below. At the third pain such as anxiety and loss of self-control. The ther- dressing change the patients were asked to choose one of the apeutic challenge is to find methods that control pain and two techniques. relieve anxiety and at the same time avoid over-sedation During the sedation procedures a protocol was used to and a delayed recovery [1]. collect cardiopulmonary data (heart rate, non-invasive blood Patient controlled sedation (PCS) has received increasing pressure, saturation, and respiratory rate). Transcutaneous interest when it has been used to improve the conditions of PCO2 were collected using TCM3—TINA (Radiometer, Copen- patients having painful or unpleasant procedures such as hagen, Denmark). Intensity of pain was assessed using a 11- lithotripsy, colonoscopy, or dental procedures [5–7]. It is point visual analogue scale (VAS) when patients were able to important also to others that the patient controlled sedation answer during the procedure, after finishing the dressing technique has been used in these settings (lithotripsy, changes, and 10 min later. Complications were recorded, dental, colonoscopy) without anesthesia-trained personnel. whether it was possible to treat the wounds adequately (yes Presently, in clinical practice at our hospital, lithotripsy is or no), and the duration of treatment. The bispectral (BIS) done using a propofol-based PCS technique without index was monitored using the A-2000 BISTM system (Aspect anesthesia-trained personnel. The procedure is based on Medical Systems, Natick, MA, USA). The recording of all these European Guidelines for sedation and/or analgesia by non- variables started before the onset of sedation and every 3 min anaesthesiology doctors [8]. In patients with burns we are during the procedure, and up to 30 min afterwards. If a lower aware of only one dose-finding study that attempted to use BIS index appeared on the display between measurement it as an alternative to traditional ways of giving analgesics points, the lowest observed index was recorded. Within 2 h of and sedatives [9]. completion of the dressing change, each patient was asked The present study was designed to compare PCS, based on a about how they experienced the sedation and the awakening standard protocol, with routine sedation provided by anaes- from it. thetists, to assess the feasibility of PCS for adequate dressing changes, and also to assess patients’ preferences. Close 2.2. Patient controlled sedation surveillance of respiratory (respiratory rate/transcutaneously assessed PCO2) and cardiovascular (heart rate/mean arterial One hour before the dressing change all patients were given pressure) data were measured as an estimate of safety, as the their regular daytime analgesics. These comprised: acetami- aim is to, in the future and after further refinement, to nophen (Panodil1 1 g, GlaxoSmithKline Healthcare) and a implement this strategy in the care of patients with burns long-acting opioid, Oxycodone (Oxycontin1 between 5 and without using specifically trained anaesthesia personnel. 40 mg). Before the start of the procedure or the anticipated pain the patients were asked to give sedation or analgesia by the PCS device whenever they felt pain or anxiety. Anticipated 2. Patients and methods painful events were predicted during the procedure and conveyed to the patients so that they could prepare them- 2.1. Study overview selves by giving analgesia and sedation. Propofol, 20 mg/ml (Propofol-1Lipuro 20 mg/ml, Braun, After approval from the local ethics committee and informed Sweden) and alfentanil 0.5 mg/ml (Rapifen1 0.05 mg/ml, consent of the patients, 11 patients with ASA I or II scores with Janssen-Cilag, Sweden) were mixed to 14.8 mg/ml of propofol burns exceeding 10% total burn surface area (TBSA) were and 0.13 mg/ml of alfentanil in the final solution. A bag
  • 3. burns 34 (2008) 929–934 931 Table 1 – Details of the patients Patient TBSA Age ACS PCS Time Propofol Morphine Time Propofol Morphine 1 15 74 64 325 10 74 153 10 2 35 32 69 500 40 85 282 18 3 12 51 91 480 20 52 140 9 4 12 82 33 170 10 50 89 5 5 15 67 81 234 10 62 195 12 6 18 23 130 632 25 60 271 17 7 16 77 82 320 15 113 191 12 8 10 68 65 395 15 50 164 10 9 8 62 44 412 15 56 102 6 10 19 59 56 490 20 78 173 11 11 20 38 47 385 25 63 369 23 Mean 16.4 57.5 69.3* 394.8** 18.6*** 67.5* 193.5** 12.1*** S.D. 7.2 19.3 26.7 130.7 9.0 19.0 83.5 5.3 ACS = anaesthetist controlled sedation; PCS = patient controlled sedation. The doses of propofol and alfentanil were given during ACS and the first PCS. Values as mean and standard deviation (S.D.). Doses in milligrams and time in min. Total burned surface area (TBSA). *P = 0.859 (NS); **P = 0.003; ***P = 0.007. Statistical differences are shown between propofol and morphine. containing the mixture was connected to an electromecha- 3. Results nical pump (Graseby 9300 PCS, Graseby Medical Ltd., Watford, UK). Each time the button was pushed, the patient received 3.1. Details of patients (Table 1) 0.3 ml of the mixture, equivalent to 4.44 mg propofol and 0.039 mg alfentanil. No lockout period was used, which All the patients started the study with ACS followed by at least resulted in a quantity of 22.2 mg propofol and 0.20 mg two PCS. Ten of the 11 patients preferred to continue dressing alfentanil possible to give in 1 min. changes using PCS after the first ACS and PCS. One patient was For comparison and calculations the analgesic doses that of indifferent to the techniques but finally chose PCS. alfentanil was multiplied by a factor of 7, resulting in equipotent doses of morphine. Doses of fentanyl were multi- 3.2. Cardiopulmonary and surveillance data plied by the factor of 100 [10]. (Fig. 1 and Table 2) 2.3. Data analysis and statistics Differences were found for SpO2, BIS, and transcutaneous PCO2, between ACS and PCS. PCS gave higher mean SpO2 Data are presented as either mean (S.D.) or median (inter- concentrations, but lower PCO2, and less sedation according to quartile range). For the statistical analysis we used Statis- BIS monitoring. tica1 Version 6.1 (Stat Soft, Inc., Tulsa, USA). To assess During ACS there was a slight decrease in saturation (<90%) differences between groups we used the Wilcoxon Matched in two cases, the lowest respiratory rate was 8, and a lowest Pairs Test. Changes over time in surveillance data between BIS index was 48. Blood pressure (MAP) was reduced during ACS and all PCS procedures were evaluated by repeated both techniques, the lowest values being between 50 and 68% measures ANOVA. Values of P < 0.05 were accepted as of baseline. Equivalent data during PCS showed no saturation significant. value lower than 94% and no respiratory rate less than 10. The Table 2 – Cardiopulmonary data and sedation data during ACS and PCS ACS PCS Statistical differences (P) Mean (S.D.) Min–Max Mean (S.D.) Min–Max SpO2, % 98 (3) 84–100 99 (2) 94–100 0.032 RR 14 (2) 8–17 16 (5) 10–30 0.707 PtcCO2 (kPa) 5.3 (0.4) 4.5–6.2 5.2 (0.5) 4.0–6.2 0.004 BIS index 84 (11) 48–99 93 (5) 67–99 0.027 HR 80 (11) 56–118 80 (11) 65–102 0.686 MAP (mmHg) 70 (15) 33–110 83 (11) 58–115 0.663 ACS = anaesthetist controlled sedation; PCS = patient controlled sedation. Values as mean and standard deviation (S.D.). Lowest and highest values recorded are presented as Min and Max. RR = respiratory rate, PtcCO2 = transcutaneous carbon dioxide, BIS index = bispectral index, HR = heart rate and MAP = mean arterial pressure.
  • 4. 932 burns 34 (2008) 929–934 Fig. 3 – Capacity of the pump in comparison with the patients with the highest demands. The doses are presented accumulated from start to the last received dose. Time (min) is from start. Fig. 1 – BIS index during ACS (sedation controlled by anaesthetist) and patient controlled sedation (PCS). given the doses. The capacity of the pump in relation to the patients with high dose demands is shown in Fig. 3. lowest MAP recordings were within 60 and 96% of baseline. 3.4. Procedure rating by personnel Reduction in the BIS index also occurred during PCS with six recordings less than 80. After dressing changes, wound care personnel said that in all cases, during ACS and PCS, sedation was adequate and, wound 3.3. Amount of drug given (Table 1 and Fig. 2) care conditions was good. Two surgeons indicated, however, that cleansing of the wounds could have been better on two During PCS all patient requested lower doses of propofol and occasions during PCS. morphine (193.5 (83.5) and 12.1 (5.3) mg mean (S.D.)) than they were given by the anaesthetist during ACS (394.8 (130.7) and 3.5. Pain ratings (Table 3) 18.6 (9.0) mg). There was no difference in duration of procedure between PCS (67.5 (19.0) min) and ACS (69.3 The highest mean (S.D.) pain ratings recorded, during wound (26.7) min). treatment were greater for PCS (4.9 (2.4)) than for ACS (1.5 During PCS procedures, four patients had a third or less of (1,0)). Immediately and 10 min after dressing changes there the required doses. The remaining seven patients had more were no differences. than 40% of required doses. Two of the four patients given less than a third of the doses given were not satisfied with the capacity of the pump, although PCS overall was preferred. The 4. Discussion nine remaining patients were satisfied with how they were The new finding of this study is that PCS, using a standard technique with a fixed protocol comprising the drugs propofol and alfentanil, can be used successfully as an alternative to ACS for wound care in burned patients. When patients chose between PCS and ACS, they chose PCS and truly preferred being in charge of their sedation instead of relying on somebody else. Although comparable data are lacking for burns, previous studies indicated a preference for PCS during other painful or unpleasant procedures [6,7]. A sense of control, together with a more rapid and less unpleasant recovery, together with the remaining possibility of deeper sedation if necessary were reasons given for the choice of PCS in the present study. 4.1. The procedure and pain With a patient who can communicate, those who are caring Fig. 2 – Doses of propofol given by anaesthetist (ACS) for the wounds informed them if unpleasant or painful compared with the doses requested by the patients (PCS) moments were to be expected, which gives them time to give during the first PCS. the sedation and analgesia properly as described previously
  • 5. burns 34 (2008) 929–934 933 Table 3 – Intensity of pain evaluated with visual analogue scale (VAS) Patient ACS PCS VAS max VAS min 0 VAS min 10 VAS max VAS min 0 VAS min 10 1 2 4 4 5 3 0 2 0 7 3 8 5 3 3 0 4 1 4 1 1 4 0 0 0 1 0 0 5 2 0 0 3 0 0 6 2 3 1 6 1 1 7 2 0 0 3 0 0 8 2 6 3 8 4 2 9 3 2 2 5 4 2 10 2 2 2 3 3 1 11 1 1 0 8 2 0 Mean 1.45* 2.64** 1.45*** 4.91* 2.09** 0.91*** S.D. 1.04 2.42 1.44 2.39 1.81 1.04 ACS = anaesthetist controlled sedation; PCS = patient controlled sedation. Values as mean and standard deviation (S.D.). Maximum pain score (VAS max in table) represent highest pain experienced during changing dressings and VAS min 0 is the pain intensity immediate after treatment. 10 min after dressing change pain intensity was again asked for (VAS min 10). *P = 0.003; **P = 0.234; ***P = 0.109. [6]. As this was the first series of PCS in this unit, the procedure present sedation. PCS itself is a factor in the satisfaction might be refined further as personnel get more acquainted among patients having cataract surgery, whether they did use with the technique. We noticed that although special the pump with propofol or not [11] which in some way may emphasis was placed on preparing the patients and predicting contribute to acceptance of the pain recorded in our study. painful events, this was at times missed and may together with the sometimes impatient behaviour of the personnel 4.2. Safety explain the intermittently high VAS scores recorded during care of the wound and PCS. Astonishingly, despite the high Despite the fact that this study used propofol and alfentanil in VAS reported, it did not seem to affect the patients overall concentrations higher than evaluated previously [6,7,11,12] judgement of the technique. To optimise the procedure, and a device without a lock out time, PCS was accomplished therefore, further training may lead to less pain without the without extreme values in cardiopulmonary or BIS data. The need to change the doses of any drugs. The finding that the patients were monitored closely and were given supplemen- length of the procedures done by ACS and PCS did not differ tary oxygen and it is therefore unlikely that any adverse also suggests that PCS was adequate. reaction has been overlooked. In all, we recorded no single We made an interesting, new discovery during this trial. In value that indicated compromise of breathing or circulation. all patients verbal complaints of pain (with corresponding The fact that the corresponding decrease in the BIS index was higher VAS scores) were not always accompanied by pressure also minor supports this further. One must, however, be on the button to release the drug. There seemed to be cautious about the strength of this conclusion, as the number cognitive dysfunction with the present drugs and protocol of patients was small. where, despite patients verbally complaining of pain, they The smaller amounts of analgesic and sedative used in the were unable to process that into the action of providing study is probably the explanation for there being fewer themselves with more of the drug. No extra doses were given symptoms of sedation after the procedure, which also by any bystander. explains the lack of effects on circulation and breathing. The high scores for pain recorded, and which seem unreasonably high, argues for more analgesic. This could 4.3. Sedation effects theoretically be accomplished either by increasing the dose of alfentanil given by PCS or by the supplementation of a longer- BIS monitoring was used to acquire objective data about the acting analgesic at the start of the procedure. This must to be state of sedation, instead of using sedation scales, which often examined further. We must point out that not a single patient involve some interactivity with the patient [7]. BIS indexes reached the maximum capacity of the pump; however, at the were collected during the procedure with no major distur- same time it is difficult to give the maximum dose as there is a bances. The position of the patient’s head must be still and hidden lockout time during which the pump delivers a dose controlled as the BIS monitor detects muscular movement, already requested. An alternative is to increase the volume of and the signal quality may then be affected. We had few such alfentanil, but that will only be achieved with less propofol, problems. BIS monitoring has been evaluated with propofol which will result in reduced sedation (given that the Graseby sedation and is a good predictor of the level of sedation [13]. pump as presently sold commercially delivers only a fixed However, there is a lag time between decreasing values and maximum volume). As far as we know patients appreciate the the outcome of an observer’s assessment [14]. As the purpose
  • 6. 934 burns 34 (2008) 929–934 was not to delineate minor changes but rather to establish work. This study is performed on clinical basis of the Burn sedation levels, mainly for the group using PCS, we do not Unit, with no external influence. think that this has an impact on the interpretation of our results. As for PCS, few values were recorded below 80%, references which is similar to the findings made by Coimbra et al. [9]. The lowest values were present during ACS, which has been a common finding by other authors who compared ASC and PCS ´ [1] Latarjet J, Choiniere M. Pain in burn patients. Burns such as in, colonoscopy [6]. In that study the corresponding 1995;21:344–8. figures were 58 (ACS) and 71 (ACS), respectively. [2] Ashburn M. Burn pain: the management of procedure- related pain. J Burn Care Rehabil 1995;16:365–71. 4.4. Other issues [3] MacLennan N, Heimbach D, Cullen B. Anesthesia for major thermal injury. Anesthesiology 1998;89:749–70. There are some other issues of importance that should be [4] Jonsson CE, Holmsten A, Dahlstrom L, Jonsson K. ¨ discussed. Background pain in burn patients: routine measurement and recording of pain intensity in a burn unit. Burns Firstly, when we compare PCS and ACS we must 1998;24:448–54. emphasise that the present standard in Sweden is to use [5] Alhashemi JA, Kaki AM. Anesthesiologist-controlled versus ACS for patients with major burns. We know that inter- patient-controlled propofol sedation for shockwave nationally many units do their dressings with no anaesthetist lithotripsy. Can J Anaesth 2006;53:449–55. support. We think that this argues for PCS as an interesting [6] Roseveare C, Seavell C, Patel P, Crisswell J, Kimble J, Jones C, alternative to the present procedure, in which anaesthetic et al. Patient-controlled sedation and analgesia, using personnel are required, and it also may explain why patients propofol and alfentanil, during colonoscopy: a prospective randomized controlled trial. Endoscopy 1998;30:768–73. accept the procedure to such a large extent with not much [7] Oei-Lim VLB, Kalkman CJ, Makkes PC, Ooms WG. Patient- sedation. The PCS technique would certainly reduce con- controlled versus anesthesiologist-controlled conscious sumption of resource. sedation with propofol for dental treatment in anxious For PCS in the present study we used a push-button device, patients. Anesth Analg 1998;86:967–72. which made it difficult to recruit patients with burnt hands. [8] Knape JTA, Adriaensen H, van Aken H, Blunnie WP, These are common among our patients [15]. Several candi- Carlsson C, Dupont M, et al. Guidelines for sedation and/or dates for the investigation were also excluded for this reason. analgesia by non-anaesthesiology doctors. Eur J Anaesthesiol 2007;24:563–7. There are, however, other techniques that could be tried for ´ [9] Coimbra C, Choiniere M, Hemmerling TM. Patient- these patients. controlled sedation using propofol for dressing changes in The study was not blind; unfortunately this is not possible burn patients: a dose-finding study. Anesth Analg with these techniques. We claimed that we used ‘‘true PCS’’, as 2003;97:839–42. no ‘‘lockout’’ time was used. This is not completely true as in [10] Wood M, Alastair JJ. Drugs and anesthesia: pharmacology practice there is a lockout time when the pump is giving the for anesthesiologist, 2nd ed., Williams & Williams; 1990. [11] Herrick IA, Gelb AW, Nichols B, Kirkby T. Patient-controlled actual dose. This time is in the range of 15 s, and may explain propofol sedation for elderly patients: safety and patient the discrepancy between the doses requested and the doses attitude toward control. Can J Anaesth 1996;43:1014–8. delivered. [12] Sim KM, Hwang NC, Chan YW, Sean CS. Use of patient- In conclusion, PCS as presented in this study using a fixed controlled analgesia with alfentanil for burns dressing protocol appears an interesting alternative to ACS for dressing procedures: a preliminary report of five patients. Burns changes in serious burns. The patients chose PCS, and 1996;22:238–41. preferred it because they had better control and less sedation [13] Schraag S, Bothner U, Gajraj R, Kenny GN, Georgieff M. The performance of electroencephalogram bispectral index and after the procedure despite having less sedation during it and auditory evoked potential index to predict loss of more pain. consciousness during propofol infusion. Anesth Analg 1999;89:1311–5. [14] Chen SC, Rex DK. An initial investigation of bispectral Conflict of interest monitoring as an adjunct to nurse-administered propofol sedation for colonoscopy. Am J Gastroenterol 2004;99:1081–6. None of the authors have any financial or personal relation- [15] Smith MA, Munster AM, Spence RJ. Burns of the hand and upper limb—a review. Burns 1998;24:493–505. ship with people or organizations that could influence this