Objectives: To evaluate the efficacy of celecoxib as an analgesic and medical expulsive agent in acute renal colic. Methods: A prospective randomized double-blind study was conducted on patients presenting with an obstructing ureteral calculus < 10 mm in largest diameter. Patients were randomized to 400 mg of celecoxib, followed by 200 mg every 12 hours for 10 days, or to placebo. Patients with a solitary kidney, renal insufficiency (CR > 1.8), urinary tract infection, or significant cardiovascular disease were excluded. Results: A total of 57 patients provided consent of which 53 completed the study. Four patients were excluded from the analysis because of stone passage or withdrawal of consent before the first dose of study medication. No significant difference was noted in the spontaneous stone passage rate (celecoxib 55.2%, placebo 54.2%) and between celecoxib and placebo with regard to days to stone passage (7.0 vs 9.0, P = .6) or size of stone passed (3.9 vs 4.6 mm, P = .18). No significant difference was noted in pain analog scores (2.6 vs 3.5, P = .71) or narcotic doses (13.2 vs 13.6, P = .74). Furthermore, a 25% decrease in narcotic use (or 19 mg based on placebo mean) was outside the 80% one-sided confidence interval for the change in mean narcotic use between the 2 groups. Thus, it is unlikely (< 20%) that we missed a clinically significant beneficial effect of celecoxib on narcotic consumption because of sample size. Conclusions: Celecoxib does not facilitate stone passage or decrease narcotic requirements in patients with acute renal colic.
Bibliographical noteFunding Information:
This study underwent Institutional Review Board Approval at 2 medical institutions, and all patients provided informed consent before participation in this study. Funding was provided by Pfizer Pharmaceuticals. No funding agreement limits were placed on our ability to complete and publish our research, and we had full control of primary data, analysis, and interpretation. In compliance with the Food and Drug Administration Amendments Act of 2007, this study was registered on http://www.clinicaltrials.gov (study NCT00304317 ).
Copyright 2011 Elsevier B.V., All rights reserved.