不再使用安慰剂:婴儿使用甜味溶液控制疼痛


  【24drs.com】一篇新统合分析的作者们结论指出,甜味溶液显然有助缓解新生儿疼痛,后续的安慰剂控制试验是不需要的、也是不道德的。
  
  加拿大渥太华大学护理学院、安大略研究中心附设儿童医院Denise Harrison博士等人在在线发表于12月16日小儿科期刊的论文中写道,未来的新生儿疼痛研究,需要选择更具道德责任的对照组。
  
  之前的两篇统合分析(一篇是以蔗糖为主的溶液、一篇是以非蔗糖如葡萄糖的溶液)得到相同的结论,但是,它们的分析方法仅允许纳入少量试验,那些作者们因为程序、结果、使用的溶液类型与其它因素之广泛变化而排除了数十个试验。
  
  因此,Harrison博士等人选择了一个可纳入之前分析曾考量之所有试验的设计,亦即所有论及哭泣时间或复合疼痛评分等行为结果的研究。作者们纳入了自1991年起发表、检测甜味溶液做为新生儿止痛药之168篇研究,总计汇集了其中62篇试验的资料进行新的分析。
  
  整体而言,50篇试验的3,341名婴儿发现,相对于对照组或安慰剂,甜味溶液的疼痛评分标准化平均差为:-0.90(95%信赖区间:-1.09 至-0.70)。至于哭泣时间,29篇试验的1,775名婴儿中,甜味溶液的平均差为:-23.18秒(95%信赖区间:-28.89至 -17.47)。
  
  作者们写道,自从最初几篇试验发表以来,有足够证据显示,相较于没有治疗或安慰剂,甜味溶液减少了哭泣时间的行为反应与复合疼痛强度评分。
  
  在2001年,新生儿疼痛国际实证小组发表指引建议使用蔗糖溶液于疼痛处理。不过,自那时起,仍进行著包括没有治疗之对照组的研究,结论也都没有改变。2016年2月更新的考科蓝回顾发现,高质量的证据显示,24%的蔗糖容易减少静脉穿刺、足跟穿刺、肌肉注射时的疼痛。
  
  Harrison博士等人写道,虽然我们对于婴儿疼痛研究还有许多需要学习之处,我们必须保持确认使用当前的证据以减少疼痛,同时,继续促进对于生病或健康之早产儿与足月儿的疼痛管理科学。
  
  作者们结论指出,我们的立场是,继续对婴儿进行安慰剂或无治疗之对照试验是不道德的。
  
  资料来源:http://www.24drs.com/
  
  Native link:No More Placebos: Sweet Solutions Control Pain in Infants

No More Placebos: Sweet Solutions Control Pain in Infants

By Beth Skwarecki
Medscape Medical News

Sweet solutions clearly help mitigate pain in newborns, and further placebo-controlled trials are not needed or ethical, the authors of a new meta-analysis conclude.

"Future neonatal pain studies need to select more ethically responsible control groups," Denise Harrison, PhD, of the Children's Hospital of Ontario Research Institute and the School of Nursing at the University of Ottawa, Canada, and colleagues write in an article published online December 16 in Pediatrics.

Two previous meta-analyses — one on sucrose-based solutions and one on their nonsucrose counterparts, including glucose — had come to the same conclusion, but their methodology only allowed a small number of trials to be included. Those authors had excluded dozens of trials because of the wide variation in procedures, outcomes, types of solution used, and other factors.

Therefore, Dr Harrison and colleagues chose a design that included all the trials the previous reviews had considered, as long as they reported behavioral outcomes of crying duration or composite pain scores. In total, the authors included 168 studies published since 1991 that tested sweet solutions as a neonatal analgesic. They were able to pool data for 62 of the trials for the new analysis.

Overall, 50 trials of 3341 infants found a standardized mean difference in pain scores of ?0.90 in favor of the sweet solutions over control or placebo (95% confidence interval, ?1.09 to ?0.70). For crying time, the mean difference was ?23.18 seconds in favor of sweet solutions (95% confidence interval, ?28.89 to ?17.47) in 29 trials totaling 1775 infants.

"[S]ince the first few trials were published, there was sufficient evidence to show that sweet solutions reduce behavioral responses of crying time and composite pain intensity scores compared with no treatment or placebo," the authors write.

In 2001, the International Evidence Based Group for Neonatal Pain published guidelines recommending the use of sucrose solutions for painful procedures. However, studies with a no-treatment control have continued to be conducted since then, with no change in conclusions. A Cochrane review updated in February 2016 found high-quality evidence for a 24% solution of sucrose to reduce pain during venipuncture, heel lance, and intramuscular injections.

"Although we still have much to learn from research on pain in infants, we must remain cognizant of using current evidence to reduce pain while we continue to advance the science of pain management in sick and healthy preterm and term infants," Dr Harrison and colleagues write.

"[I]t is our position that it is unethical to continue to conduct placebo or no-treatment controlled trials in infants," the authors conclude.

The authors have disclosed no relevant financial relationships.

Pediatrics. Published online December 16, 2016.

    
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