Whittaker Marianne R
New Hampshire's Hospital for Children at Elliot Health System, Manchester, New Hampshire.
J Pediatr Pharmacol Ther. 2013 Oct;18(4):269-76. doi: 10.5863/1551-6776-18.4.269.
Pediatric patients may be at an increased risk of adverse effects from various medications. Recently, there have been a number of serious adverse events, including several pediatric patients experiencing severe respiratory depression and death as a result of the use of codeine for pain control following tonsillectomy and adenoidectomy.
To assess the safety of opioid agonists in pediatric patients undergoing operative procedures or have experienced trauma and to evaluate the risk of respiratory depression and death among this population.
PubMed and Medline were searched to identify randomized controlled studies from 1994 to 2012 addressing postsurgery/trauma opioid use in pediatric patients. Relative risks and confidence intervals (CIs) were calculated using data available in clinical trials.
A total of 16 clinical trials were evaluated for this review. Randomized controlled trials included studies comparing opioids versus non-opioids for a variety of painful conditions. The relative risk of respiratory depression associated with opioid use in 1 trial was 1.63 (95% CI: 0.64-6.13). The remaining 15 trials reviewed described no significant difference in respiratory depression or adverse effects associated with treatment. No deaths were attributed to opioid use in any of these studies.
Opioid-associated respiratory depression was very rare and no deaths were reported in the reviewed studies. These findings under the well-defined conditions of controlled studies may not be the best means of determining overall opioid-associated side effects in pediatric patients.
儿科患者使用各种药物时发生不良反应的风险可能会增加。最近,出现了一些严重不良事件,包括几名儿科患者在扁桃体切除术后和腺样体切除术后使用可待因控制疼痛时出现严重呼吸抑制和死亡。
评估阿片类激动剂在接受手术或遭受创伤的儿科患者中的安全性,并评估该人群中呼吸抑制和死亡的风险。
检索PubMed和Medline,以确定1994年至2012年期间针对儿科患者术后/创伤后使用阿片类药物的随机对照研究。使用临床试验中的可用数据计算相对风险和置信区间(CI)。
本次综述共评估了16项临床试验。随机对照试验包括比较阿片类药物与非阿片类药物用于各种疼痛状况的研究。1项试验中与使用阿片类药物相关的呼吸抑制相对风险为1.63(95%CI:0.64-6.13)。其余15项综述试验描述了呼吸抑制或与治疗相关的不良反应无显著差异。在这些研究中,没有死亡归因于使用阿片类药物。
在综述的研究中,阿片类药物相关的呼吸抑制非常罕见,且未报告死亡病例。在对照研究的明确条件下得出的这些结果可能不是确定儿科患者中阿片类药物总体相关副作用的最佳方法。