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小儿扁桃体切除术后曲马多与可待因/对乙酰氨基酚的比较:一项前瞻性、双盲、随机对照试验。

Tramadol versus codeine/acetaminophen after pediatric tonsillectomy: A prospective, double-blinded, randomized controlled trial.

作者信息

Friedrichsdorf Stefan J, Postier Andrea C, Foster Laurie Pane, Lander Timothy A, Tibesar Robert J, Lu Yi, Sidman James D

机构信息

Medical Director, Department of Pain Medicine, Palliative Care & Integrative Medicine, Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota; Associate Professor of Pediatrics, University of Minnesota Medical School, Minneapolis, Minnesota.

Department of Pain Medicine, Palliative Care & Integrative Medicine, Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota.

出版信息

J Opioid Manag. 2015 Jul-Aug;11(4):283-94. doi: 10.5055/jom.2015.0277.

DOI:10.5055/jom.2015.0277
PMID:26312955
Abstract

OBJECTIVE

Tonsillectomy is one of the most common pediatric surgical procedures performed in the United States. The postoperative period can be particularly painful, and there is currently no consensus on an optimal analgesic regimen. The objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy.

DESIGN

Prospective, double-blinded, randomized controlled trial.

SETTING

Large, Midwestern US pediatric hospital.

PATIENTS

Eighty-four children aged 4-15 years who underwent a tonsillectomy (with or without adenoidectomy) procedure were randomized and 74 were included in the analysis.

INTERVENTIONS

Group 1 received liquid codeine/acetaminophen for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed). Group 2 received liquid tramadol for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed).

MAIN OUTCOME MEASURES

Efficacy and side effects were evaluated using a 10-day take-home diary that was completed by parents.

RESULTS

Children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores. Oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group, and itching was experienced by significantly more children in the tramadol group during the postoperative period.

CONCLUSIONS

As part of multimodal analgesia, scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties, low potential for side effects, and good safety profile.

摘要

目的

扁桃体切除术是美国最常见的儿科外科手术之一。术后时期可能会特别疼痛,目前对于最佳镇痛方案尚无共识。本研究的目的是评估扁桃体切除术后单药曲马多与可待因/对乙酰氨基酚的疗效和安全性。

设计

前瞻性、双盲、随机对照试验。

地点

美国中西部的一家大型儿科医院。

患者

84名4至15岁接受扁桃体切除术(伴或不伴腺样体切除术)的儿童被随机分组,74名纳入分析。

干预措施

第1组在扁桃体切除术后接受10天的可待因/对乙酰氨基酚液剂(5天按计划用药,随后5天按需用药)。第2组在扁桃体切除术后接受10天的曲马多液剂(5天按计划用药,随后5天按需用药)。

主要观察指标

使用家长完成的10天家庭日记评估疗效和副作用。

结果

两个研究组的儿童均报告扁桃体切除术后疼痛得到充分控制,两组疼痛评分无显著差异。可待因/对乙酰氨基酚组在手术当天过度镇静的发生率显著更高,曲马多组在术后期间有更多儿童出现瘙痒。

结论

作为多模式镇痛的一部分,由于其镇痛特性、低副作用可能性和良好的安全性,对于术后儿童可考虑使用按计划加按需服用的曲马多。

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