Finn Judith, Wright Jan, Fong Joy, Mackenzie Eileen, Wood Fiona, Leslie Gavin, Gelavis Anna
The School of Population Health (M431), The University of Western Australia, 35 Stirling Highway, Perth, 6009 WA, Australia.
Burns. 2004 May;30(3):262-8. doi: 10.1016/j.burns.2003.10.017.
This study sought to compare the analgesic efficacy and safety of patient controlled intra-nasal (PCIN) fentanyl with oral morphine for procedural wound care in burns patients. A randomised double-blind placebo controlled, two period, two-treatment crossover trial was conducted within the Burns Unit of a major teaching hospital in Perth, Western Australia. Patients requiring identical wound care procedures on two consecutive mornings (and not prescribed intravenous analgesia) were randomised to receive either PCIN fentanyl with oral placebo or oral morphine with intranasal placebo on 1 day, followed by the alternate active drug on the following day. Twenty-six patients (22 males), aged between 18 and 69 years (35.5 +/- 12.4 years), with total body surface burns (TBSA) range 1-25% (6.9 +/- 4.5), indicated their level of pain on a 10 point (0-10) numeric scale at various time periods before, during and after the procedure. A mean total dose of 1.48 +/- 0.57 microg/kg of PCIN fentanyl and 0.35 +/- 0.12 mg/kg of oral morphine was administered. No statistically significant difference was found between the pain scores recorded for patients during the procedure with PCIN fentanyl compared to that with oral morphine (mean difference = -0.75, 95% CI = -1.97 to 0.47, P = 0.22). Two patients experienced hypotension during the procedure--both had received active oral morphine. No patients experienced respiratory depression or a significant drop in oxygen saturation. There were four episodes (in three patients) where 'rescue analgesia' for severe pain was required--two episodes involving oral morphine and two involving PCIN fentanyl. It was concluded that PCIN fentanyl is similar in efficacy and safety to oral morphine for relief of procedural wound care pain in burns patients.
本研究旨在比较患者自控鼻内给予芬太尼(PCIN)与口服吗啡用于烧伤患者程序性伤口护理时的镇痛效果及安全性。在澳大利亚西部珀斯一家大型教学医院的烧伤科进行了一项随机双盲安慰剂对照、两阶段、双治疗交叉试验。连续两个上午需要进行相同伤口护理程序(且未开具静脉镇痛药物)的患者被随机分为两组,一组在第1天接受PCIN芬太尼加口服安慰剂,另一组接受口服吗啡加鼻内安慰剂,次日两组交换使用活性药物。26例患者(22例男性),年龄在18至69岁之间(35.5±12.4岁),全身烧伤面积(TBSA)为1%-25%(6.9±4.5),在程序进行前、期间和之后的不同时间段,用10分制(0-10)数字评分法表明其疼痛程度。PCIN芬太尼的平均总剂量为1.48±0.57μg/kg,口服吗啡的平均总剂量为0.35±0.12mg/kg。与口服吗啡相比,PCIN芬太尼用于患者程序期间记录的疼痛评分之间未发现统计学上的显著差异(平均差异=-0.75,95%CI=-1.97至0.47,P=0.22)。两名患者在程序期间出现低血压,两人均接受了活性口服吗啡。没有患者出现呼吸抑制或氧饱和度显著下降。有4次(3例患者)需要进行“急救镇痛”以缓解剧痛,其中2次涉及口服吗啡,2次涉及PCIN芬太尼。得出的结论是,在缓解烧伤患者程序性伤口护理疼痛方面,PCIN芬太尼在疗效和安全性上与口服吗啡相似。