The BUSCOPAN study: a randomized-controlled non-inferiority trial of a continuous butylscopolamine infusion versus placebo in patients with a renal colic not responding to oral non-steroidal anti-inflammatory drugs

Author:

Weltings S.ORCID,Buddingh K. T.ORCID,van Diepen D. C.ORCID,Pelger R. C. M.ORCID,Putter H.ORCID,Rad M.,Schout B. M. A.ORCID,Roshani H.

Abstract

Abstract Purpose To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic. Methods We conducted a placebo-controlled, multicenter, double-blind randomized clinical trial (RCT) including 128 patients with renal colic (confirmed by ultrasound or CT-scan). Patients were randomized to receive either continuous IV butylscopolamine 100 mg/24 h or placebo (saline). Primary outcome is the amount of opioid escape medication used, measured in doses administered. Secondary outcomes are pain measured on a Numeric Rating Scale (NRS), side effects, and time of drug administration. Non-inferiority was assessed using linear regression with robust standard errors, with non-inferiority limit set at 0.5 units of escape medication. Results Median number of doses of escape medication was one in both groups. The number of extra doses in the placebo group compared with the butylscopolamine group was 0.05, with a 95% robust confidence interval (CI) of 0.38–0.47. Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04). No differences in secondary endpoints were seen between the groups. Conclusion Placebo is non-inferior to continuous IV butylscopolamine for pain relief in patients with renal colic. Based on this study and previous evidence, there is no role for continuous butylscopolamine IV in the treatment of renal colic. Trial NL7819

Funder

Leiden University Medical Center

Publisher

Springer Science and Business Media LLC

Subject

Urology

Reference21 articles.

1. Bultitude M, Rees J (2012) Management of renal colic. BMJ Br Med J Publishing Group 345:e5499–e5509

2. Türk C, Petřík A, Sarica K, Seitz C, Skolarikos A, Straub M et al (2016) EAU guidelines on diagnosis and conservative management of urolithiasis. Euro Urol 69:468–474

3. Papadopoulos G, Bourdoumis A, Kachrilas S, Bach C, Buchholz N, Masood J (2014) Hyoscine N-butylbromide (Buscopan®) in the treatment of acute ureteral colic: what is the evidence? Urol Int Karger Publishers 92(3):253–257

4. Evidence-based richtlijn diagnostiek, behandeling en follow-up van nierstenen. Utrecht, (2014) 1–102

5. Holdgate A, Oh CM (2005) Is there a role for antimuscarinics in renal colic? A randomized controlled trial. J Urol Wolters Kluwer Philadelphia 174(2):572–575 (discussion575)

Cited by 4 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3