Ketorolac vs Morphine for Severe Vaso-Occlusive Crisis in Sickle Cell Disease: An Open-Label Randomized Controlled Trial (KISS Study).

IF 1.5 4区医学 Q2 PEDIATRICS Indian pediatrics Pub Date : 2025-01-15 DOI:10.1007/s13312-025-3351-0

Sai Pratap Reddy, Sunil Natha Jondhale, Santosh Kumar Rathia, Samreen Yusuf, Seema Shah, Anil Kumar Goel

{"title":"Ketorolac vs Morphine for Severe Vaso-Occlusive Crisis in Sickle Cell Disease: An Open-Label Randomized Controlled Trial (KISS Study).","authors":"Sai Pratap Reddy, Sunil Natha Jondhale, Santosh Kumar Rathia, Samreen Yusuf, Seema Shah, Anil Kumar Goel","doi":"10.1007/s13312-025-3351-0","DOIUrl":null,"url":null,"abstract":"Objectives: To compare the efficacy and safety of intravenous (IV) ketorolac and IV morphine in the management of severe vaso-occlusive crisis (VOC) in children with sickle cell disease (SCD).Method: An open-label, randomized controlled trial was conducted from January 2021 to July 2022 wherein children with SCD aged 3 to 15 years, presenting with severe VOC (score > 6 on the Wong-Baker Faces Pain scale) were included. Block randomization with minimization was done and participants received either IV ketorolac (intervention) or IV morphine infusion (standard). The pain score was reassessed three hourly and if the pain score exceeded 6, the drug dose was escalated every 3 hours, upto a maximum of three escalating doses. A pain score of ≤ 6 were regarded as response.Results: The mean (SD) pain scores at admission in the ketorolac and morphine groups were 9.28 (0.89) and 9.12 (1.01), respectively (P = 0.636). At 3, 6, 9, and 12 hours of infusion, the mean pain scores in the ketorolac and morphine groups were 8.04 (1.24) vs 8.28 (1.24), P = 0.313; 7.04 (1.210) vs 7.28 (1.28), P = 0.331; 6.40 (1.26) vs 6.28 (1.17), P = 0.860; and 5.56 (1.00) vs 5.60 (1.04), P = 0.817, respectively. Five and eleven children developed minor side effects in the ketorolac and morphine groups, respectively (P = 0.069). Overall, one child in the ketorolac group and two in the morphine persisted to have severe pain even after 12 hours of therapy (P = 0.55).Conclusion: Intravenous ketorolac may be considered as a good alternative to IV morphine in the management of severe VOC in SCD.","PeriodicalId":13291,"journal":{"name":"Indian pediatrics","volume":"62 1","pages":"15-19"},"PeriodicalIF":1.5000,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian pediatrics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13312-025-3351-0","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PEDIATRICS","Score":null,"Total":0}

引用次数: 0

Abstract

Objectives: To compare the efficacy and safety of intravenous (IV) ketorolac and IV morphine in the management of severe vaso-occlusive crisis (VOC) in children with sickle cell disease (SCD).

Method: An open-label, randomized controlled trial was conducted from January 2021 to July 2022 wherein children with SCD aged 3 to 15 years, presenting with severe VOC (score > 6 on the Wong-Baker Faces Pain scale) were included. Block randomization with minimization was done and participants received either IV ketorolac (intervention) or IV morphine infusion (standard). The pain score was reassessed three hourly and if the pain score exceeded 6, the drug dose was escalated every 3 hours, upto a maximum of three escalating doses. A pain score of ≤ 6 were regarded as response.

Results: The mean (SD) pain scores at admission in the ketorolac and morphine groups were 9.28 (0.89) and 9.12 (1.01), respectively (P = 0.636). At 3, 6, 9, and 12 hours of infusion, the mean pain scores in the ketorolac and morphine groups were 8.04 (1.24) vs 8.28 (1.24), P = 0.313; 7.04 (1.210) vs 7.28 (1.28), P = 0.331; 6.40 (1.26) vs 6.28 (1.17), P = 0.860; and 5.56 (1.00) vs 5.60 (1.04), P = 0.817, respectively. Five and eleven children developed minor side effects in the ketorolac and morphine groups, respectively (P = 0.069). Overall, one child in the ketorolac group and two in the morphine persisted to have severe pain even after 12 hours of therapy (P = 0.55).

Conclusion: Intravenous ketorolac may be considered as a good alternative to IV morphine in the management of severe VOC in SCD.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

酮罗拉酸与吗啡治疗镰状细胞病严重血管闭塞危像：一项开放标签随机对照试验（KISS研究）

目的：比较静脉注射（IV）酮罗拉酸与静脉注射吗啡治疗镰状细胞病（SCD）患儿严重血管闭塞危像（VOC）的疗效和安全性。方法：从2021年1月至2022年7月进行了一项开放标签的随机对照试验，其中包括3至15岁的SCD儿童，表现为严重的VOC （Wong-Baker面部疼痛量表评分为bb60）。采用最小化分组随机化，参与者接受静脉注射酮罗拉酸（干预）或静脉注射吗啡（标准）。每3小时重新评估疼痛评分，如果疼痛评分超过6分，则每3小时增加一次药物剂量，最多增加3次剂量。疼痛评分≤6分为有反应。结果：酮咯酸组和吗啡组入院时疼痛评分的平均值（SD）分别为9.28（0.89）和9.12(1.01)，差异有统计学意义（P = 0.636）。在给药3、6、9、12 h时，酮咯酸组和吗啡组的平均疼痛评分分别为8.04（1.24）比8.28 (1.24),P = 0.313；7.04 (1.210) vs 7.28 (1.28), P = 0.331；6.40 (1.26) vs 6.28 (1.17), P = 0.860；5.56 (1.00) vs 5.60 (1.04), P = 0.817。酮咯酸组和吗啡组分别有5例和11例患儿出现轻微副作用（P = 0.069）。总的来说，酮罗拉酸组的一个孩子和吗啡组的两个孩子在治疗12小时后仍然有严重的疼痛（P = 0.55）。结论：静脉注射酮罗拉酸可作为静脉注射吗啡治疗重度挥发性有机化合物的较好选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Indian pediatrics 医学-小儿科

CiteScore

3.30

自引率

8.70%

发文量

344

审稿时长

3-8 weeks

期刊介绍： The general objective of Indian Pediatrics is "To promote the science and practice of Pediatrics." An important guiding principle has been the simultaneous need to inform, educate and entertain the target audience. The specific key objectives are: -To publish original, relevant, well researched peer reviewed articles on issues related to child health. -To provide continuing education to support informed clinical decisions and research. -To foster responsible and balanced debate on controversial issues that affect child health, including non-clinical areas such as medical education, ethics, law, environment and economics. -To achieve the highest level of ethical medical journalism and to produce a publication that is timely, credible and enjoyable to read.