口服氯胺酮用于急性术后镇痛（OKAPA）试验：随机对照单中心试点研究。

IF 5 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2024-11-21 DOI:10.1016/j.jclinane.2024.111690

Michael Dinsmore MD, PhD, FRCPC , Kristof Nijs MD, MSc , Eric Plitman PhD , Emad Al Azazi MD, PhD , Lashmi Venkatraghavan MD, DNB, FRCA, FRCPC , Karim Ladha MD, MSc , Hance Clarke MD

{"title":"口服氯胺酮用于急性术后镇痛（OKAPA）试验：随机对照单中心试点研究。","authors":"Michael Dinsmore MD, PhD, FRCPC , Kristof Nijs MD, MSc , Eric Plitman PhD , Emad Al Azazi MD, PhD , Lashmi Venkatraghavan MD, DNB, FRCA, FRCPC , Karim Ladha MD, MSc , Hance Clarke MD","doi":"10.1016/j.jclinane.2024.111690","DOIUrl":null,"url":null,"abstract":"<div><h3>Study objective</h3><div>Although opioids represent the mainstay of treating surgical pain, their use is associated with significant side effects. There is an urgent need to find new pain relievers with safer side effect profiles. One drug that has been receiving increasing attention is ketamine. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. This study aims to examine the role of oral ketamine in improving recovery after major spine surgery.</div></div><div><h3>Design</h3><div>A prospective, single-center, double blinded parallel arm, placebo controlled randomized feasibility trial.</div></div><div><h3>Setting</h3><div>Toronto Western Hospital (TWH), UHN, Toronto, Canada.</div></div><div><h3>Patients</h3><div>Adult patients (aged 18–75) undergoing multi-level lumbar spine decompression and fusion with planned overnight admission in hospital.</div></div><div><h3>Interventions</h3><div>Study treatment (oral ketamine 30 mg) or matching placebo for three days (nine doses total) or until hospital discharge.</div></div><div><h3>Measurements</h3><div>The primary outcome was the patient-reported Quality of Recovery-15 score (QoR-15). Secondary outcomes were opioid use, pain intensity, pain interference (PROMIS-pain interference questionnaire), mood (PHQ-9) and, side-effects (Generic Assessment of Side Effects Scale).</div></div><div><h3>Main results</h3><div>Data from 35 patients were analyzed, of which 18 patients in the ketamine group and 17 patients in the placebo group. There were no significant differences identified in QoR-15 scores at postoperative days 1,3,7, and 30. There were also no significant differences found in pain intensity scale scores at postoperative days 1, 3, 7, and 30, and PROMIS and PHQ-9 scores at postoperative days 7 and 30. Significantly less oral opioids were used in the ketamine group compared to the placebo group on postoperative day 3 and by postoperative day 7. In addition, patients in the ketamine group spent significantly less days on oral opioids and trended to be discharged from hospital earlier.</div></div><div><h3>Conclusion</h3><div>This pilot study demonstrated that low dose oral ketamine can be safely used as an adjunct in postoperative pain treatment to help reduce opioid consumption after major spine surgery.</div></div>","PeriodicalId":15506,"journal":{"name":"Journal of Clinical Anesthesia","volume":"100 ","pages":"Article 111690"},"PeriodicalIF":5.0000,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Oral ketamine for acute postoperative analgesia (OKAPA) trial: A randomized controlled, single center pilot study\",\"authors\":\"Michael Dinsmore MD, PhD, FRCPC , Kristof Nijs MD, MSc , Eric Plitman PhD , Emad Al Azazi MD, PhD , Lashmi Venkatraghavan MD, DNB, FRCA, FRCPC , Karim Ladha MD, MSc , Hance Clarke MD\",\"doi\":\"10.1016/j.jclinane.2024.111690\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Study objective</h3><div>Although opioids represent the mainstay of treating surgical pain, their use is associated with significant side effects. There is an urgent need to find new pain relievers with safer side effect profiles. One drug that has been receiving increasing attention is ketamine. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. This study aims to examine the role of oral ketamine in improving recovery after major spine surgery.</div></div><div><h3>Design</h3><div>A prospective, single-center, double blinded parallel arm, placebo controlled randomized feasibility trial.</div></div><div><h3>Setting</h3><div>Toronto Western Hospital (TWH), UHN, Toronto, Canada.</div></div><div><h3>Patients</h3><div>Adult patients (aged 18–75) undergoing multi-level lumbar spine decompression and fusion with planned overnight admission in hospital.</div></div><div><h3>Interventions</h3><div>Study treatment (oral ketamine 30 mg) or matching placebo for three days (nine doses total) or until hospital discharge.</div></div><div><h3>Measurements</h3><div>The primary outcome was the patient-reported Quality of Recovery-15 score (QoR-15). Secondary outcomes were opioid use, pain intensity, pain interference (PROMIS-pain interference questionnaire), mood (PHQ-9) and, side-effects (Generic Assessment of Side Effects Scale).</div></div><div><h3>Main results</h3><div>Data from 35 patients were analyzed, of which 18 patients in the ketamine group and 17 patients in the placebo group. There were no significant differences identified in QoR-15 scores at postoperative days 1,3,7, and 30. There were also no significant differences found in pain intensity scale scores at postoperative days 1, 3, 7, and 30, and PROMIS and PHQ-9 scores at postoperative days 7 and 30. Significantly less oral opioids were used in the ketamine group compared to the placebo group on postoperative day 3 and by postoperative day 7. In addition, patients in the ketamine group spent significantly less days on oral opioids and trended to be discharged from hospital earlier.</div></div><div><h3>Conclusion</h3><div>This pilot study demonstrated that low dose oral ketamine can be safely used as an adjunct in postoperative pain treatment to help reduce opioid consumption after major spine surgery.</div></div>\",\"PeriodicalId\":15506,\"journal\":{\"name\":\"Journal of Clinical Anesthesia\",\"volume\":\"100 \",\"pages\":\"Article 111690\"},\"PeriodicalIF\":5.0000,\"publicationDate\":\"2024-11-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Anesthesia\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0952818024003192\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ANESTHESIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Anesthesia","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0952818024003192","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

研究目的虽然阿片类药物是治疗手术疼痛的主要药物，但使用这类药物会产生严重的副作用。目前迫切需要找到副作用更安全的新型止痛药。氯胺酮是一种越来越受关注的药物。通过口服给药途径，氯胺酮有可能以较少的资源密集型方式供患者使用，且疗效相似。本研究旨在探讨口服氯胺酮在改善脊柱大手术后恢复方面的作用：前瞻性、单中心、双盲、平行臂、安慰剂对照随机可行性试验：多伦多西区医院（TWH），UHN，加拿大多伦多：成人患者（18-75 岁），接受多层次腰椎减压和融合术，计划住院过夜：干预措施：研究治疗（口服氯胺酮 30 毫克）或匹配安慰剂，为期三天（共九次）或直至出院：主要结果是患者报告的康复质量-15评分（QoR-15）。次要结果为阿片类药物的使用、疼痛强度、疼痛干扰（PROMIS-疼痛干扰问卷）、情绪（PHQ-9）和副作用（副作用通用评估量表）：分析了 35 名患者的数据，其中氯胺酮组 18 人，安慰剂组 17 人。术后第1、3、7和30天的QoR-15评分无明显差异。术后第1、3、7和30天的疼痛强度量表评分以及术后第7和30天的PROMIS和PHQ-9评分也无明显差异。与安慰剂组相比，氯胺酮组患者在术后第 3 天和术后第 7 天口服阿片类药物的次数明显减少。此外，氯胺酮组患者口服阿片类药物的天数明显减少，出院时间也有提前的趋势：这项试验性研究表明，小剂量口服氯胺酮可作为术后疼痛治疗的辅助药物安全使用，有助于减少脊柱大手术后阿片类药物的用量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Oral ketamine for acute postoperative analgesia (OKAPA) trial: A randomized controlled, single center pilot study

Study objective

Although opioids represent the mainstay of treating surgical pain, their use is associated with significant side effects. There is an urgent need to find new pain relievers with safer side effect profiles. One drug that has been receiving increasing attention is ketamine. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. This study aims to examine the role of oral ketamine in improving recovery after major spine surgery.

Design

A prospective, single-center, double blinded parallel arm, placebo controlled randomized feasibility trial.

Setting

Toronto Western Hospital (TWH), UHN, Toronto, Canada.

Patients

Adult patients (aged 18–75) undergoing multi-level lumbar spine decompression and fusion with planned overnight admission in hospital.

Interventions

Study treatment (oral ketamine 30 mg) or matching placebo for three days (nine doses total) or until hospital discharge.

Measurements

The primary outcome was the patient-reported Quality of Recovery-15 score (QoR-15). Secondary outcomes were opioid use, pain intensity, pain interference (PROMIS-pain interference questionnaire), mood (PHQ-9) and, side-effects (Generic Assessment of Side Effects Scale).

Main results

Data from 35 patients were analyzed, of which 18 patients in the ketamine group and 17 patients in the placebo group. There were no significant differences identified in QoR-15 scores at postoperative days 1,3,7, and 30. There were also no significant differences found in pain intensity scale scores at postoperative days 1, 3, 7, and 30, and PROMIS and PHQ-9 scores at postoperative days 7 and 30. Significantly less oral opioids were used in the ketamine group compared to the placebo group on postoperative day 3 and by postoperative day 7. In addition, patients in the ketamine group spent significantly less days on oral opioids and trended to be discharged from hospital earlier.

Conclusion

This pilot study demonstrated that low dose oral ketamine can be safely used as an adjunct in postoperative pain treatment to help reduce opioid consumption after major spine surgery.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.