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

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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

Original languageEnglish
Pages (from-to)2747-2752
Number of pages6
JournalWorld Journal of Urology
Volume39
Issue number7
DOIs
Publication statusPublished - 19 Apr 2021

Bibliographical note

Funding Information:
A research grant of €2000 was given by the science bureau of Haga teaching hospital. No other funding was received.

Publisher Copyright:
© 2020, The Author(s).

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