- Email: [email protected]
Factors in the choice of oral transmucosal fentanyl citrate dose for adult burns dressings
burns 35 (2009) 798–801
available at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/burns
Factors in the choice of oral transmucosal fentanyl citrate dose for adult burns dressings H. Shah a,*, J. Smythe a, Z. Hanafiah b, G.J.P. Williams b, A. Holdcroft a,b a b
Imperial College London, UK Chelsea and Westminster Hospital, NHS Foundation Trust, London, UK
article info
abstract
Article history:
Factors that influenced the choice of dose of oral transmucosal fentanyl at the time of burns
Accepted 29 September 2008
dressing change were investigated in a prospective study. After Ethics committee approval, data was analysed from 29 consecutive patients who had been recruited and consented for a
Keywords:
study of pain associated with burns dressings. Patients had completed an 11-point verbal
Fentanyl
pain intensity score (VRS) prior to and after the dressing change. Analgesic use during for
Transmucosal
this period was documented. Doses of 600 to 1200 mcg of transmucosal fentanyl (Actiq1)
Burns
were given based on individual assessment. The pre-dressing VRS (median [range]) in the 15
Pain
patients who received 600 mcg was 8 [3–10] and was higher than the VRS of 6 [2–9] in the 800–
Wound dressing
1200 mcg group. The time since the burn was longer in the low dose group at 7 [1–22] days compared with 5 [0–50] days in the higher dose group. In addition 73% of the low dose group was prescribed opioids regularly prior to the dressing compared with 57% of the high dose group. The choice of a lower transmucosal fentanyl dose was based on prior use of opioids and the age of the burn rather than on the patient’s pain intensity. # 2008 Elsevier Ltd and ISBI. All rights reserved.
1.
Introduction
The pain intensity of hospitalised burns patients though often severe and constantly present is frequently under-estimated and exacerbated by painful interventions [1–3]. Episodes of increased pain intensity vary greatly between people and may not be related to mobility or the amount of analgesia prescribed so that analgesia has to be individually titrated [4]. Reviews of standard in-patient pharmacological therapies identify that oral opioids are the most commonly administered analgesics [3,5]. In addition to routine pain management, procedural pain will necessitate pain relief. During burns dressings the pain is often of short duration but intense. In the past oral morphine has been used extensively but shorter acting opioid drugs are now available. Target controlled
infusions of alfentanil have been used in this situation but they rely on intravenous access [6]. Alternatively, sedatives have been used synergistically with opioids due to anxiety components of pain expressed by patients [7]. However, this synergy resulted in further cardio-respiratory depression as an inherent problem. Oral transmucosal fentanyl was another option because of its short action and rapid onset [8]. After reviewing the literature, reporting a local procedural pain audit and using oral transmucosal fentanyl in our unit we hypothesised that choice of dose would be individualised and based on patient’s reported pain intensity and weight. To confirm this we initiated a prospective descriptive study to determine the motivation for decisions on fentanyl dosage in the context of the prevailing guidance for procedural pain management.
* Corresponding author at: 52 Powys lane, Palmers Green, London N13 4HS, UK. E-mail address: [email protected] (H. Shah). 0305-4179/$36.00 # 2008 Elsevier Ltd and ISBI. All rights reserved. doi:10.1016/j.burns.2008.09.014
799
burns 35 (2009) 798–801
2.
Methods
After research Ethics Committee approval, adult patients with combined 2nd and 3rd degree burns admitted consecutively to the Burns Unit at Chelsea and Westminster Hospital, London were recruited over six months according to inclusion and exclusion criteria. Patients were included if they were scheduled for dressings at the burn site and excluded if they were unable to complete the baseline pain assessments or had a history of drug abuse. Eligible patients were consented a day before burns wound dressing change and their age, weight, % of the total body surface area burned and days since burn recorded. A verbal pain score was requested 1–2 h before the dressing and within an hour after the burns dressing. An 11-point Likert scale was used with numeric scores from ‘0’ being no pain and ‘10’ as the worst pain imaginable. For patients where physical activity with their hands may be limited, this method was considered to have a similar sensitivity to a continuous visual analogue scale [9]. After the burns dressing, the type of analgesic drug given before and during the procedure was recorded. The pre-dressing in-patient prescriptions of opioidtype drugs such as oral morphine, codeine and Tramadol were identified. There were 2-year old medical guidelines on analgesic management for pain relief before and during burns dressings for junior doctors and nurses. The use of an antiemetic was advised together with an opioid drug. The nurse administering the fentanyl was asked to use the prescribed dose (400 mcg) and to ‘top this up with 200 mcg doses every 15 min until an optimal dose’ was achieved. There was no guidance on other analgesic doses or on the use of pain scores. The data collected from the study was analysed using Statistical Package for the Social Sciences (SPSS Inc., Chicago, IL) version 15.0. Appropriate statistical tests were performed for parametric and non-parametric data including Chi Square, Mann Whitney and repeated measures ANOVA. A p < 0.05 was considered to be statistically significant.
Fig. 1 – The sequence of doses given to study patients.
during past burns dressings. The doses delivered to patients over the time of the study demonstrated no time based trend for an increased or decreased dose (Fig. 1). There were no reported adverse effects and only a few patients received antiemetics. Patient’s age, weight and percentage burn showed no statistically significant effect on the dose of transmucosal fentanyl chosen as shown in Table 1. The days since the burn was longer in the low dose group with 40% being more than 8 days since the burn compared with 29% in the higher dose group. The low dose group also had more patients prescribed opioids prior to the burns dressing than patients in the high dose group, 73% compared with 50% respectively, and they had higher pain intensity scores based on the VRS before burns dressings (Fig. 2). These trends were not statistically significant. Once the analgesic management and burns dressing had been completed, pain intensity in both groups decreased as shown in Table 1. Within each group this decrease was highly statistically significant, p = 0.007 (low dose group) and p = 0.04 (high dose group) using ANOVA for repeated measures.
4. 3.
Results
Forty patients were enrolled into the study and 29 received oral transmucosal fentanyl (Actiq1). Of these patients, 15 received 600 mcg (termed ‘low dose’ group) and the others 800 mcg except one who had 1200 mcg (‘high dose’ group). Reasons for not using the transmucosal fentanyl included patients’ physical limitations and preferences developed
Discussion
In circumstances where there were written guidelines on dosage of oral transmucosal fentanyl we found that there was a trend to use lower doses in patients who were receiving opioids prior to burns dressings and who had had the burn for longer. The dose chosen was not related to the patient’s physical characteristics, such as age or weight, or to the pain intensity suffered by the patient before the burns dressing as shown in Fig. 2.
Table 1 – The demographic data and pain intensity in low (600 mcg) and high (=800 mcg) dose groups of transmucosal fentanyl. VRS = verbal rating scale [median (range)]. Low dose group n = 15 Age (years) Weight (kg) % body surface area burned Days since burn >8 days Pre-dressing opioids prescribed VRS before dressing VRS <1 h after dressing
41 75 5 7 6 11 8 5
(18–79) (58–107) (1–20) (1–22)
(3–10) (2–8)
High dose group n = 14 44 (19–73) 68 (55–102) 5.5 (1–44) 5 (0–50) 4 7 6 (2–9) 4.5 (1–6)
p value 0.771 0.150 0.320 0.556 0.700 0.450 0.270 0.354
800
burns 35 (2009) 798–801
Fig. 2 – The variations in pain intensity measured as the verbal rating scale (VRS) across the low and high dose groups.
The dose of fentanyl has been related to a patient’s weight in children’s and adult’s studies. In a study of eight children, doses of oral transmucosal fentanyl of 10 mcg/kg were compared with oral morphine and pain measures were improved with fentanyl at this dose [8]. In two other crossover studies in a total of 36 children scheduled for burn wound care, oral transmucosal fentanyl in a dose of 10 mcg/kg was compared with oral hydromorphone or oxycodone; in these patients there were no problems relating to safety or palatability [10,11]. In contrast, in an audit study of a mixed aged group of children and adults when the dose of intravenous fentanyl was retrospectively calculated, a mean dose of 8 mcg/kg (range 0.7–38 mcg/kg) was required for the first burns wound procedure and transient respiratory depression was observed in 31% [12]. For intranasal fentanyl in a randomised cross over trial with oral morphine, 26 adults required a mean dose of 1.48 mcg/kg fentanyl [13]. Our dose regime was a fixed starting dose of 400 mcg with top up doses of 200 mcg until pain relief was adequate. There was no maximum dose and this guidance had been in place for over two years. In practice, doctors wrote the prescription and the nurse in charge of the burns dressing administered the drug. Hence there was the opportunity for a nurse/patient interaction and because of a prior pain audit on the ward involving the nursing staff, verbal pain scoring by the patient was encouraged. Our study showed that in general 600 and 800 mcg doses of oral transmucosal fentanyl were being used and 1200 mcg was the maximum dose. In a recent study of oral transmucosal fentanyl for general dressing changes in 9 patients, a starting dose of 200 mcg up to a maximum dose of 400 mcg was selected but over half the patients required escape analgesia [14]. Previously, for postoperative pain management, 800 mcg of oral transmucosal fentanyl was found to be of similar potency to 10 mg iv morphine and with a similar frequency of respiratory depression [15]. Our doses were therefore divided into two, one below the 10 mg morphine equivalent and the other equal to or above. We consider that this regime may not be optimal because the median pain intensity scores were high. However in both dose groups pain intensity significantly decreased after the administration of the fentanyl. The choice of a lower dose of fentanyl to manage procedural pain seems to have been based in some patients on their background of regular opioid prescriptions and the longer age of the burn. At the same time we have identified
that these patients were reporting greater pain scores. The result seems to be counterintuitive. We have to consider if the pain intensity was not recognised by staff, if staff were fearful of adverse effects in the presence of other opioid drugs or if decisions on fentanyl dose were made for other reasons. Support for staff empathy to patients’ pain intensity comes from a UK burns unit where most patients rated burns’ procedural pain as none or mild and almost all staff recorded pain of higher intensity [16]. The results of our study do not include nurse or doctors rating of patient’s pain intensity. It is possible that the high level of pain across the study patients made staff focus on other aspects on which to make their decisions on the dose of fentanyl. In a continuing education journal for anaesthetists where pain in the patient with burns was reviewed, opioids were reported to ‘result in respiratory depression particularly if given to a patient already receiving opioids’ [17]. Although this is a safety clause it can generate unwanted anxiety in health care staff particularly if they lack confidence in managing complications or are unable to question dogma. For example, for years in cancer pain management breakthrough oral morphine has been administered in a dose related to the patient’s regular dose of morphine. However, such a regime has not worked well for pain relief and there is now evidence from patients who receive regular opioids for cancer pain management that the dose of oral transmucosal fentanyl is not directly related to the dose of regular opioid [18,19]. Another scenario that may cause concern to staff is the use of multiple doses of oral transmucosal fentanyl in a procedural situation. In healthy volunteers without additional pain medications the pharmacokinetics of single and multiple doses have confirmed a lack of cumulation [20,21] but staff may inaccurately assume there is a fentanyl depot, as occurs with skin patches, and additional studies are needed to replicate the context of background opioid use. The results of this study demonstrate that clinical care and outcome can be influenced by unpredictable behaviour. For example, titration of analgesia appeared not to be related to pain intensity. We found trends that suggested that when staff and patients could flexibly titrate a dose of oral transmucosal fentanyl, the factors that influenced this dose were not those expected based on pain intensity.
Acknowledgements The authors thank the Burns Unit staff and patients at Chelsea and Westminster Hospital, London, for their support and Cephalon for a grant towards the study analysis and travel costs for Dr. Shah. Cephalon had no involvement in the study design, analysis and manuscript preparation.
references
[1] Choinie`re M, Melzack R, Rondeau J, Girard N, Paquin M-J. The pain of burns: characteristics and correlates. Eur J Anaesthesiol 1989;29:1531–9. [2] Jonsson C-E, Holmsten A, Dahlstro¨m L, Jonsson K. Background pain in burn patients: routine measurement and
burns 35 (2009) 798–801
[3] [4]
[5] [6]
[7]
[8]
[9]
[10]
[11]
[12]
recording of pain intensity in a burn unit. Eur J Anaesthesiol 1998;24:448–54. Latarjet J, Choinie`re M. Pain in burn patients. Eur J Anaesthesiol 1995;21:344–8. Hagen NA, Fisher K, Vicotrino C, Farrar JT. A titration strategy is needed to manage breakthrough cancer pain effectively: observations from data pooled from three clinical trials. Eur J Anaesthesiol 2007;10:47–55. Pal SK, Cortiella J, Herndon D. Adjunctive methods of pain control in burns. Eur J Anaesthesiol 1997;23:404–12. Gallagher G, Rae CP, Kenny GN, Kinsella J. The use of a target-controlled infusion of alfentanil to provide analgesia for burn dressing changes. Eur J Anaesthesiol 2000;55:1159– 63. Coimbra C, Choinie`re M, Hemmerling M. Patient-controlled sedation using propofol for dressing changes in burn patients: a dose finding study. Eur J Anaesthesiol 2003;97:839–42. Robert R, Brack A, Blakeney P, Villarreal C, Rosenberg L, Thomas C, et al. A double-blind study of the analgesic efficacy of oral transmucosal fentanyl citrate and oral morphine in pediatric patients undergoing burn dressing change and tubbing. Eur J Anaesthesiol 2003;24:351–5. Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Eur J Anaesthesiol 2000;16:22–8. Sharar SR, Bratton SL, Carrougher GJ, Edwards WT, Summer G, Levy FH, et al. A comparative trial of oral transmucosal fentanyl citrate and oral hydromorphone for inpatient pediatric burn wound care analgesia. Eur J Anaesthesiol 1998;19:516–21. Sharar SR, Carrougher GJ, Selzer K, O’Donnell F, Vavilala MS, Lee LA. A comparison of oral transmucosal fentanyl citrate and oral oxycodone for pediatric outpatient wound care. Eur J Anaesthesiol 2002;23:27–31. Linneman PK, Terry BE, Burd RS. The efficacy and safety of fentanyl for the management of severe procedural pain in patients with burn injuries. Eur J Anaesthesiol 2000;21:519– 22.
801
[13] Finn J, Wright J, Fong J, Mackenzie E, Wood F, Leslie G, et al. A randomised crossover trial of patient controlled intranasal fentanyl and oral morphine for procedural wound care in adult patients with burns. Eur J Anaesthesiol 2004;30: 262–8. [14] MacIntyre PA, Margetts L, Larsen D, Barker L. Oral transmucosal fentanyl citrate versus placebo for painful dressing changes: a crossover trial. Eur J Anaesthesiol 2007;16: 118–21. [15] Lichtor JL, Sevarino FB, Joshi GP, Busch MA, Nordbrock E, Ginsberg B. The relative potency of oral transmucosal fentanyl citrate compared with intravenous morphine in the treatment of moderate to severe postoperative pain. Eur J Anaesthesiol 1999;89:732–8. [16] Rae CP, Gallagher G, Watson S, Kinsella J. An audit of patient perception compared with medical and nursing staff estimation of pain during burn dressing changes. Eur J Anaesthesiol 2000;17:43–5. [17] Norman AT, Judkins KC. Pain in the patient with burns. Eur J Anaesthesiol 2004;4:57–61. [18] Portenoy RK, Payne R, Coluzzi P, Raschko JW, Lyss A, Busch MA, et al. Oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough pain in cancer patients: a controlled dose titration study. Eur J Anaesthesiol 1999;79:303–12. [19] Hanks G. Oral transmucosal fentanyl citrate for the management of breakthrough pain. Eur J Anaesthesiol 2001;8:6–9. [20] Streisand JB, Varvel JR, Stanski DR, Le Maire L, Ashburn MA, Hague BI, et al. Absorption and bioavailability of oral transmucosal fentanyl citrate. Eur J Anaesthesiol 1991;75:223–9. [21] Egan TD, Sharma A, Ashburn MA, Kievit J, Pace NL, Streisand JB. Multiple dose pharmacokinetics of oral transmucosal fentanyl citrate in healthy volunteers. Eur J Anaesthesiol 2000;92:665–73.
available at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/burns
Factors in the choice of oral transmucosal fentanyl citrate dose for adult burns dressings H. Shah a,*, J. Smythe a, Z. Hanafiah b, G.J.P. Williams b, A. Holdcroft a,b a b
Imperial College London, UK Chelsea and Westminster Hospital, NHS Foundation Trust, London, UK
article info
abstract
Article history:
Factors that influenced the choice of dose of oral transmucosal fentanyl at the time of burns
Accepted 29 September 2008
dressing change were investigated in a prospective study. After Ethics committee approval, data was analysed from 29 consecutive patients who had been recruited and consented for a
Keywords:
study of pain associated with burns dressings. Patients had completed an 11-point verbal
Fentanyl
pain intensity score (VRS) prior to and after the dressing change. Analgesic use during for
Transmucosal
this period was documented. Doses of 600 to 1200 mcg of transmucosal fentanyl (Actiq1)
Burns
were given based on individual assessment. The pre-dressing VRS (median [range]) in the 15
Pain
patients who received 600 mcg was 8 [3–10] and was higher than the VRS of 6 [2–9] in the 800–
Wound dressing
1200 mcg group. The time since the burn was longer in the low dose group at 7 [1–22] days compared with 5 [0–50] days in the higher dose group. In addition 73% of the low dose group was prescribed opioids regularly prior to the dressing compared with 57% of the high dose group. The choice of a lower transmucosal fentanyl dose was based on prior use of opioids and the age of the burn rather than on the patient’s pain intensity. # 2008 Elsevier Ltd and ISBI. All rights reserved.
1.
Introduction
The pain intensity of hospitalised burns patients though often severe and constantly present is frequently under-estimated and exacerbated by painful interventions [1–3]. Episodes of increased pain intensity vary greatly between people and may not be related to mobility or the amount of analgesia prescribed so that analgesia has to be individually titrated [4]. Reviews of standard in-patient pharmacological therapies identify that oral opioids are the most commonly administered analgesics [3,5]. In addition to routine pain management, procedural pain will necessitate pain relief. During burns dressings the pain is often of short duration but intense. In the past oral morphine has been used extensively but shorter acting opioid drugs are now available. Target controlled
infusions of alfentanil have been used in this situation but they rely on intravenous access [6]. Alternatively, sedatives have been used synergistically with opioids due to anxiety components of pain expressed by patients [7]. However, this synergy resulted in further cardio-respiratory depression as an inherent problem. Oral transmucosal fentanyl was another option because of its short action and rapid onset [8]. After reviewing the literature, reporting a local procedural pain audit and using oral transmucosal fentanyl in our unit we hypothesised that choice of dose would be individualised and based on patient’s reported pain intensity and weight. To confirm this we initiated a prospective descriptive study to determine the motivation for decisions on fentanyl dosage in the context of the prevailing guidance for procedural pain management.
* Corresponding author at: 52 Powys lane, Palmers Green, London N13 4HS, UK. E-mail address: [email protected] (H. Shah). 0305-4179/$36.00 # 2008 Elsevier Ltd and ISBI. All rights reserved. doi:10.1016/j.burns.2008.09.014
799
burns 35 (2009) 798–801
2.
Methods
After research Ethics Committee approval, adult patients with combined 2nd and 3rd degree burns admitted consecutively to the Burns Unit at Chelsea and Westminster Hospital, London were recruited over six months according to inclusion and exclusion criteria. Patients were included if they were scheduled for dressings at the burn site and excluded if they were unable to complete the baseline pain assessments or had a history of drug abuse. Eligible patients were consented a day before burns wound dressing change and their age, weight, % of the total body surface area burned and days since burn recorded. A verbal pain score was requested 1–2 h before the dressing and within an hour after the burns dressing. An 11-point Likert scale was used with numeric scores from ‘0’ being no pain and ‘10’ as the worst pain imaginable. For patients where physical activity with their hands may be limited, this method was considered to have a similar sensitivity to a continuous visual analogue scale [9]. After the burns dressing, the type of analgesic drug given before and during the procedure was recorded. The pre-dressing in-patient prescriptions of opioidtype drugs such as oral morphine, codeine and Tramadol were identified. There were 2-year old medical guidelines on analgesic management for pain relief before and during burns dressings for junior doctors and nurses. The use of an antiemetic was advised together with an opioid drug. The nurse administering the fentanyl was asked to use the prescribed dose (400 mcg) and to ‘top this up with 200 mcg doses every 15 min until an optimal dose’ was achieved. There was no guidance on other analgesic doses or on the use of pain scores. The data collected from the study was analysed using Statistical Package for the Social Sciences (SPSS Inc., Chicago, IL) version 15.0. Appropriate statistical tests were performed for parametric and non-parametric data including Chi Square, Mann Whitney and repeated measures ANOVA. A p < 0.05 was considered to be statistically significant.
Fig. 1 – The sequence of doses given to study patients.
during past burns dressings. The doses delivered to patients over the time of the study demonstrated no time based trend for an increased or decreased dose (Fig. 1). There were no reported adverse effects and only a few patients received antiemetics. Patient’s age, weight and percentage burn showed no statistically significant effect on the dose of transmucosal fentanyl chosen as shown in Table 1. The days since the burn was longer in the low dose group with 40% being more than 8 days since the burn compared with 29% in the higher dose group. The low dose group also had more patients prescribed opioids prior to the burns dressing than patients in the high dose group, 73% compared with 50% respectively, and they had higher pain intensity scores based on the VRS before burns dressings (Fig. 2). These trends were not statistically significant. Once the analgesic management and burns dressing had been completed, pain intensity in both groups decreased as shown in Table 1. Within each group this decrease was highly statistically significant, p = 0.007 (low dose group) and p = 0.04 (high dose group) using ANOVA for repeated measures.
4. 3.
Results
Forty patients were enrolled into the study and 29 received oral transmucosal fentanyl (Actiq1). Of these patients, 15 received 600 mcg (termed ‘low dose’ group) and the others 800 mcg except one who had 1200 mcg (‘high dose’ group). Reasons for not using the transmucosal fentanyl included patients’ physical limitations and preferences developed
Discussion
In circumstances where there were written guidelines on dosage of oral transmucosal fentanyl we found that there was a trend to use lower doses in patients who were receiving opioids prior to burns dressings and who had had the burn for longer. The dose chosen was not related to the patient’s physical characteristics, such as age or weight, or to the pain intensity suffered by the patient before the burns dressing as shown in Fig. 2.
Table 1 – The demographic data and pain intensity in low (600 mcg) and high (=800 mcg) dose groups of transmucosal fentanyl. VRS = verbal rating scale [median (range)]. Low dose group n = 15 Age (years) Weight (kg) % body surface area burned Days since burn >8 days Pre-dressing opioids prescribed VRS before dressing VRS <1 h after dressing
41 75 5 7 6 11 8 5
(18–79) (58–107) (1–20) (1–22)
(3–10) (2–8)
High dose group n = 14 44 (19–73) 68 (55–102) 5.5 (1–44) 5 (0–50) 4 7 6 (2–9) 4.5 (1–6)
p value 0.771 0.150 0.320 0.556 0.700 0.450 0.270 0.354
800
burns 35 (2009) 798–801
Fig. 2 – The variations in pain intensity measured as the verbal rating scale (VRS) across the low and high dose groups.
The dose of fentanyl has been related to a patient’s weight in children’s and adult’s studies. In a study of eight children, doses of oral transmucosal fentanyl of 10 mcg/kg were compared with oral morphine and pain measures were improved with fentanyl at this dose [8]. In two other crossover studies in a total of 36 children scheduled for burn wound care, oral transmucosal fentanyl in a dose of 10 mcg/kg was compared with oral hydromorphone or oxycodone; in these patients there were no problems relating to safety or palatability [10,11]. In contrast, in an audit study of a mixed aged group of children and adults when the dose of intravenous fentanyl was retrospectively calculated, a mean dose of 8 mcg/kg (range 0.7–38 mcg/kg) was required for the first burns wound procedure and transient respiratory depression was observed in 31% [12]. For intranasal fentanyl in a randomised cross over trial with oral morphine, 26 adults required a mean dose of 1.48 mcg/kg fentanyl [13]. Our dose regime was a fixed starting dose of 400 mcg with top up doses of 200 mcg until pain relief was adequate. There was no maximum dose and this guidance had been in place for over two years. In practice, doctors wrote the prescription and the nurse in charge of the burns dressing administered the drug. Hence there was the opportunity for a nurse/patient interaction and because of a prior pain audit on the ward involving the nursing staff, verbal pain scoring by the patient was encouraged. Our study showed that in general 600 and 800 mcg doses of oral transmucosal fentanyl were being used and 1200 mcg was the maximum dose. In a recent study of oral transmucosal fentanyl for general dressing changes in 9 patients, a starting dose of 200 mcg up to a maximum dose of 400 mcg was selected but over half the patients required escape analgesia [14]. Previously, for postoperative pain management, 800 mcg of oral transmucosal fentanyl was found to be of similar potency to 10 mg iv morphine and with a similar frequency of respiratory depression [15]. Our doses were therefore divided into two, one below the 10 mg morphine equivalent and the other equal to or above. We consider that this regime may not be optimal because the median pain intensity scores were high. However in both dose groups pain intensity significantly decreased after the administration of the fentanyl. The choice of a lower dose of fentanyl to manage procedural pain seems to have been based in some patients on their background of regular opioid prescriptions and the longer age of the burn. At the same time we have identified
that these patients were reporting greater pain scores. The result seems to be counterintuitive. We have to consider if the pain intensity was not recognised by staff, if staff were fearful of adverse effects in the presence of other opioid drugs or if decisions on fentanyl dose were made for other reasons. Support for staff empathy to patients’ pain intensity comes from a UK burns unit where most patients rated burns’ procedural pain as none or mild and almost all staff recorded pain of higher intensity [16]. The results of our study do not include nurse or doctors rating of patient’s pain intensity. It is possible that the high level of pain across the study patients made staff focus on other aspects on which to make their decisions on the dose of fentanyl. In a continuing education journal for anaesthetists where pain in the patient with burns was reviewed, opioids were reported to ‘result in respiratory depression particularly if given to a patient already receiving opioids’ [17]. Although this is a safety clause it can generate unwanted anxiety in health care staff particularly if they lack confidence in managing complications or are unable to question dogma. For example, for years in cancer pain management breakthrough oral morphine has been administered in a dose related to the patient’s regular dose of morphine. However, such a regime has not worked well for pain relief and there is now evidence from patients who receive regular opioids for cancer pain management that the dose of oral transmucosal fentanyl is not directly related to the dose of regular opioid [18,19]. Another scenario that may cause concern to staff is the use of multiple doses of oral transmucosal fentanyl in a procedural situation. In healthy volunteers without additional pain medications the pharmacokinetics of single and multiple doses have confirmed a lack of cumulation [20,21] but staff may inaccurately assume there is a fentanyl depot, as occurs with skin patches, and additional studies are needed to replicate the context of background opioid use. The results of this study demonstrate that clinical care and outcome can be influenced by unpredictable behaviour. For example, titration of analgesia appeared not to be related to pain intensity. We found trends that suggested that when staff and patients could flexibly titrate a dose of oral transmucosal fentanyl, the factors that influenced this dose were not those expected based on pain intensity.
Acknowledgements The authors thank the Burns Unit staff and patients at Chelsea and Westminster Hospital, London, for their support and Cephalon for a grant towards the study analysis and travel costs for Dr. Shah. Cephalon had no involvement in the study design, analysis and manuscript preparation.
references
[1] Choinie`re M, Melzack R, Rondeau J, Girard N, Paquin M-J. The pain of burns: characteristics and correlates. Eur J Anaesthesiol 1989;29:1531–9. [2] Jonsson C-E, Holmsten A, Dahlstro¨m L, Jonsson K. Background pain in burn patients: routine measurement and
burns 35 (2009) 798–801
[3] [4]
[5] [6]
[7]
[8]
[9]
[10]
[11]
[12]
recording of pain intensity in a burn unit. Eur J Anaesthesiol 1998;24:448–54. Latarjet J, Choinie`re M. Pain in burn patients. Eur J Anaesthesiol 1995;21:344–8. Hagen NA, Fisher K, Vicotrino C, Farrar JT. A titration strategy is needed to manage breakthrough cancer pain effectively: observations from data pooled from three clinical trials. Eur J Anaesthesiol 2007;10:47–55. Pal SK, Cortiella J, Herndon D. Adjunctive methods of pain control in burns. Eur J Anaesthesiol 1997;23:404–12. Gallagher G, Rae CP, Kenny GN, Kinsella J. The use of a target-controlled infusion of alfentanil to provide analgesia for burn dressing changes. Eur J Anaesthesiol 2000;55:1159– 63. Coimbra C, Choinie`re M, Hemmerling M. Patient-controlled sedation using propofol for dressing changes in burn patients: a dose finding study. Eur J Anaesthesiol 2003;97:839–42. Robert R, Brack A, Blakeney P, Villarreal C, Rosenberg L, Thomas C, et al. A double-blind study of the analgesic efficacy of oral transmucosal fentanyl citrate and oral morphine in pediatric patients undergoing burn dressing change and tubbing. Eur J Anaesthesiol 2003;24:351–5. Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Eur J Anaesthesiol 2000;16:22–8. Sharar SR, Bratton SL, Carrougher GJ, Edwards WT, Summer G, Levy FH, et al. A comparative trial of oral transmucosal fentanyl citrate and oral hydromorphone for inpatient pediatric burn wound care analgesia. Eur J Anaesthesiol 1998;19:516–21. Sharar SR, Carrougher GJ, Selzer K, O’Donnell F, Vavilala MS, Lee LA. A comparison of oral transmucosal fentanyl citrate and oral oxycodone for pediatric outpatient wound care. Eur J Anaesthesiol 2002;23:27–31. Linneman PK, Terry BE, Burd RS. The efficacy and safety of fentanyl for the management of severe procedural pain in patients with burn injuries. Eur J Anaesthesiol 2000;21:519– 22.
801
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