Hobson Anna, Wiffen Philip J, Conlon Joy A
Cochrane Pain, Palliative and Supportive Care Group, Pain Research Unit, The Churchill Hospital, Old Road, Oxford, UK, OX3 7LE.
Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD011404. doi: 10.1002/14651858.CD011404.pub2.
Acute postoperative pain occurs as a result of tissue damage following surgery. Administering the appropriate analgesia to children is a complex process and it is unclear whether children's postoperative pain is more successfully treated by using 'as required' (when pain occurs) (termed 'pro re nata' or PRN) or (irrespective of pain at the time of administration).
To assess the efficacy of as required versus fixed schedule analgesic administration for the management of postoperative pain in children under the age of 16 years.
On 2 July 2014, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL databases. We reviewed the bibliographies of all included studies and of reviews, and searched two clinical trial databases, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform, to identify additional published or unpublished data.
We included randomised controlled trials (RCTs) comparing PRN versus ATC analgesic administration for postoperative pain in children under the age of 16 years who had undergone any surgical procedure requiring postoperative pain relief, in any setting.
Two review authors (AH, PW) independently extracted efficacy and adverse event data, examined issues of study quality, and assessed risk of bias as recommended in the Cochrane Handbook for Systematic Reviews of Interventions.
We included three RCTs (four reports) of 246 children aged under 16 years undergoing tonsillectomy. Children were given weight-appropriate doses of the study medication, either PRN or ATC, by a parent or carer at home for up to four days following surgery. We did not identify any studies assessing the management of postoperative pain in children in any other setting (i.e. as an inpatient). All studies included in this review were based on the use of paracetamol, and an opioid was added to paracetamol in two studies. Analgesics were administered either orally (tablet or elixir) or rectally (suppository). Reporting quality was poor and there were fewer than 50 children in each arm. Mean pain intensity scores decreased over time, as did medication use. However, children were still reporting pain at the final assessment, suggesting that no administration schedule provided adequate analgesia. There were no significant differences in pain intensity scores at any time point. The studies reported adverse events that may have been related to the study medication, such as nausea and vomiting, and constipation, but no statistically significant differences were noted between the groups. There were too few data from only three small studies and meta-analysis was not possible. One study reported that a higher amount of analgesics was consumed in the ATC group compared with the PRN group: it would have been helpful to show that the higher volume in the ATC group led to better analgesia but we were not able to demonstrate this.
AUTHORS' CONCLUSIONS: There was limited evidence available to draw any conclusions about the efficacy of PRN versus ATC analgesic administration for the management of postoperative pain in children.
术后急性疼痛是手术造成组织损伤的结果。给儿童使用恰当的镇痛方法是一个复杂的过程,目前尚不清楚对于儿童术后疼痛,采用“按需”(疼痛发生时)(称为“必要时”或PRN)给药还是(不论给药时是否疼痛)定时给药能更成功地进行治疗。
评估按需给药与定时给药用于16岁以下儿童术后疼痛管理的疗效。
2014年7月2日,我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE和CINAHL数据库。我们查阅了所有纳入研究及综述的参考文献,并检索了两个临床试验数据库ClinicalTrials.gov和世界卫生组织(WHO)国际临床试验注册平台,以识别其他已发表或未发表的数据。
我们纳入了比较PRN与定时(ATC)给药用于16岁以下接受任何需要术后镇痛的手术的儿童术后疼痛的随机对照试验(RCT),试验在任何环境下进行。
两名综述作者(AH,PW)独立提取疗效和不良事件数据,检查研究质量问题,并按照Cochrane干预措施系统评价手册中的建议评估偏倚风险。
我们纳入了3项RCT(4篇报告),共246名16岁以下接受扁桃体切除术的儿童。术后长达4天,家长或照顾者在家中按儿童体重给予适当剂量的研究药物,采用PRN或ATC给药方式。我们未识别出任何评估其他环境下(即住院时)儿童术后疼痛管理的研究。本综述纳入的所有研究均基于对乙酰氨基酚的使用,两项研究在对乙酰氨基酚中添加了阿片类药物。镇痛药通过口服(片剂或酏剂)或直肠(栓剂)给药。报告质量较差,每组儿童少于50名。随着时间推移,平均疼痛强度评分和药物使用量均下降。然而,在最终评估时儿童仍报告有疼痛,这表明没有哪种给药方案能提供充分的镇痛效果。在任何时间点,疼痛强度评分均无显著差异。研究报告了可能与研究药物相关的不良事件,如恶心、呕吐和便秘,但两组之间未观察到统计学上的显著差异。由于仅有3项小型研究,数据过少,无法进行荟萃分析。一项研究报告称,与PRN组相比,ATC组消耗的镇痛药更多:若能表明ATC组较高的用药量带来了更好的镇痛效果将很有帮助,但我们无法证实这一点。
关于PRN与ATC给药用于儿童术后疼痛管理的疗效,现有证据有限,难以得出任何结论。