Objective: To evaluate the effect of adding butylscopolammonium bromide (BB) to morphine and ketorolac in the treatment of acute renal colic in the ED.
Methods: A prospective, double-blind, randomized controlled trial of i.v. triple therapy (morphine, ketorolac and BB) versus double therapy (morphine and ketorolac) in adult ED patients with a clinical diagnosis of acute renal colic and a pain rating greater than five on a 10 cm visual analogue scale (VAS). VAS was recorded at time 0, 20 and 40 min. Patients received rescue morphine at 20 or 40 min according to the protocol if needed. We compared pain reduction and the need for rescue analgesia at 4 min between two groups.
Results: Eighty-nine patients were randomized over a 13 month period. A total of 46 (51.7%) patients received BB in addition to morphine and ketorolac. The mean difference in change in pain score in the triple therapy group and double therapy group was 7.1 cm (95% CI 6.4-7.8) and 5.9 cm (95% CI 5.1-6.7), respectively (P= 0.024). Rescue morphine was required by 7/46 (15.2% [95% CI 4.4-20.6]) patients in the triple therapy group and 14/43 (32.6% [95% CI 18.0-47.1]) in the double therapy group (OR 0.37 [95% CI 0.133-1.038]).
Conclusions: Although the addition of BB to morphine and ketorolac appeared to show a statistically significant reduction in pain compared with morphine and ketorolac alone, a reduction of 1.2 cm on VAS is unlikely to be clinically significant.
© 2011 The Authors. EMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.