The BUSCOPAN study: a randomized-controlled non-inferiority trial of a continuous butylscopolamine infusion versus place
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ORIGINAL ARTICLE
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. Weltings1 · K. T. Buddingh1 · D. C. van Diepen2 · R. C. M. Pelger3 · H. Putter3 · M. Rad1 · B. M. A. Schout4 · H. Roshani1 Received: 6 June 2020 / Accepted: 10 September 2020 © The Author(s) 2020
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 Keywords Urolithiasis · Ureteral calculi · Renal colic · Butylscopolammonium bromide
Introduction A renal colic, mostly produced by a calculus in the upper urinary tract, is one of the most severe forms of pain known. Non-steroidal anti-inflammatory drugs (NSAIDs) are the agents of first choice to control the pain in these patients. If NSAIDs are insufficient or contra-indicated, * S. Weltings [email protected] 1
Haga Teaching Hospital, The Hague, The Netherlands
2
Erasmus MC, Rotterdam, The Netherlands
3
LUMC, Leiden, The Netherlands
4
Alrijne Health Group, Leiderdorp, The Netherlands
titrated intravenous (IV) or intramuscular opioids are generally recommended as a second step [1, 2]. Additionally, anticholinergic spasmolytic drugs have been prescribed to patients with renal colic since the nineteenth century [3]. The rationale is that such drugs may induce smooth-muscle relaxation by inhibition of the action of acetylcholine on the muscarinic receptors in the wall of the ureter. One type of antimuscarinic that received interest over the past decades is butylscopolamine. In the Netherlands, continuous IV infusion of butylscopolamine has long been used for
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