儿童腺样体扁桃体切除术后预防性使用安乃近镇痛疗效的评价：一项随机临床试验
Evaluation of the Analgesic Efficacy of Preemptive Dipyrone in the Postoperative Period of Adenotonsillectomy in Children: A Randomized Clinical Trial.
文献信息
| PMID | 42877878 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Maira I S Stangler |
| 作者单位 | Graduate Program of Pediatrics at UFCSPA, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. |
| 期刊 | International archives of otorhinolaryngology |
| SCI 分区 | Q3 |
| IF | 1.4 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
引言： 安乃近是最常用的术后镇痛药之一。然而，仅有两项随机、安慰剂对照临床试验评估了其在儿童扁桃体切除术中的效果。
目的： 比较儿童腺样体扁桃体切除术中切皮前使用安乃近或安慰剂后的术后疼痛结局。
方法： 这是一项随机、双盲、平行、安慰剂对照临床试验，纳入接受腺样体扁桃体切除术的4至14岁儿童。共76名参与者被随机分为干预/安乃近组（n=39）和安慰剂组（n=37）。所有参与者在两个时间点之一接受安乃近或生理盐水（安慰剂）：手术切皮前或手术结束时。
结果： 平均年龄为6.8岁，体重为32.1 kg。在干预组中，生命体征正常，仅7.7%出现呕吐，而安慰剂组为8.1%。安乃近组进食提前1.1小时。两组在所有评估时间点（H0、H1、H3和H6）均有至少77.6%的参与者疼痛得到控制。在H3时，干预组54.2%的参与者疼痛得到控制，而安慰剂组为45.8%。此外，安乃近组在H1和H3显示出阿片类药物需求降低的趋势，与安慰剂相比，阿片类药物给药分别减少了50%和52.63%。
结论： 在接受预防性安乃近的组中观察到疼痛缓解、更早接受饮食以及阿片类药物需求降低的趋势。结果未达到统计学显著性，可能是由于II型错误。
英文摘要
INTRODUCTION: Dipyrone is one of the most commonly used postoperative analgesics. However, there are only two randomized, placebo-controlled clinical trials evaluating its effect in pediatric tonsillectomies.
OBJECTIVE: To compare postoperative pain outcomes following the use of pre-incisional dipyrone or placebo in pediatric adenotonsillectomy.
METHODS: This was a randomized, double-blind, parallel, placebo-controlled clinical trial in children aged 4 to 14 years who underwent adenotonsillectomy. A total of 76 participants were randomized into the intervention/dipyrone group (n = 39) and the placebo group (n = 37). All received either dipyrone or saline solution (placebo) at one of two time points: before the surgical incision or at the end of surgery.
RESULTS: The mean age was 6.8 years and weight was 32.1 kg. In the intervention group, vital signs were normal and only 7.7% experienced emesis, compared with 8.1% in the placebo group. Food intake was anticipated by 1,1 hours in the dipyrone group. Pain was controlled in at least 77.6% of participants at all evaluated time points (H0, H1, H3, and H6) in both groups. At H3, pain was controlled in 54.2% of the intervention group compared with 45.8% in the placebo group. In addition, the dipyrone group demonstrated a tendency toward a lower need for opioids in H1 and H3, reducing opioid administration by 50% and 52.63%, respectively, compared with placebo.
CONCLUSION: A trend toward pain relief, earlier diet acceptance, and a lower need for opioids was observed in the group that received preemptive dipyrone. The results did not reach statistical significance, likely due to a type II error.