不再使用安慰劑:嬰兒使用甜味溶液控制疼痛


  【24drs.com】一篇新統合分析的作者們結論指出,甜味溶液顯然有助緩解新生兒疼痛,後續的安慰劑控制試驗是不需要的、也是不道德的。
  
  加拿大渥太華大學護理學院、安大略研究中心附設兒童醫院Denise Harrison博士等人在線上發表於12月16日小兒科期刊的論文中寫道,未來的新生兒疼痛研究,需要選擇更具道德責任的對照組。
  
  之前的兩篇統合分析(一篇是以蔗糖為主的溶液、一篇是以非蔗糖如葡萄糖的溶液)得到相同的結論,但是,它們的分析方法僅允許納入少量試驗,那些作者們因為程序、結果、使用的溶液類型與其他因素之廣泛變化而排除了數十個試驗。
  
  因此,Harrison博士等人選擇了一個可納入之前分析曾考量之所有試驗的設計,亦即所有論及哭泣時間或複合疼痛評分等行為結果的研究。作者們納入了自1991年起發表、檢測甜味溶液做為新生兒止痛藥之168篇研究,總計匯集了其中62篇試驗的資料進行新的分析。
  
  整體而言,50篇試驗的3,341名嬰兒發現,相對於對照組或安慰劑,甜味溶液的疼痛評分標準化平均差為:-0.90(95%信賴區間:-1.09 至-0.70)。至於哭泣時間,29篇試驗的1,775名嬰兒中,甜味溶液的平均差為:-23.18秒(95%信賴區間:-28.89至 -17.47)。
  
  作者們寫道,自從最初幾篇試驗發表以來,有足夠證據顯示,相較於沒有治療或安慰劑,甜味溶液減少了哭泣時間的行為反應與複合疼痛強度評分。
  
  在2001年,新生兒疼痛國際實證小組發表指引建議使用蔗糖溶液於疼痛處理。不過,自那時起,仍進行著包括沒有治療之對照組的研究,結論也都沒有改變。2016年2月更新的考科藍回顧發現,高品質的證據顯示,24%的蔗糖容易減少靜脈穿刺、足跟穿刺、肌肉注射時的疼痛。
  
  Harrison博士等人寫道,雖然我們對於嬰兒疼痛研究還有許多需要學習之處,我們必須保持確認使用當前的證據以減少疼痛,同時,繼續促進對於生病或健康之早產兒與足月兒的疼痛管理科學。
  
  作者們結論指出,我們的立場是,繼續對嬰兒進行安慰劑或無治療之對照試驗是不道德的。
  
  資料來源: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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