Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Abstract

It is estimated over 20 million people aged 20‐74 have gallbladder disease, with biliary colic being a common and painful symptom in these patients. Likely due to the relatively recent approval of intravenous ibuprofen use for fever and pain in adults, no assessment of its analgesic efficacy for biliary colic currently exists in the literature. In this double‐blind, randomized, controlled trial we aim to assess the analgesic efficacy of intravenous (IV) ibuprofen given in the emergency department (ED) for the treatment of biliary colic. Analgesic efficacy was evaluated using a visual analog scale (VAS) to assess for a decrease in pain scores. A VAS score decrease of 33% in relation to the VAS taken at the time of therapy drug administration was considered a minimum clinically important difference (MCID) in patient‐perceived pain. A VAS was administered in triage upon enrollment, at the time of therapy administration, at 15‐minute intervals during the first hour post‐administration, and 30‐minute intervals in the second hour. As the standard of care for suspected biliary colic at the study institution is administration of a one‐time dose of IV morphine, patients were not denied initial morphine analgesia and were permitted to receive “rescue” morphine analgesia at any point during their ED course. A total of 22 patients completed the study. 9 were randomized to the IV ibuprofen arm, 9 to placebo, and 4 were excluded for a diagnosis other than biliary colic. Mean VAS values at time 0 to time 120 decreased from 5.78 to 2.31 in the ibuprofen group, and from 5.89 to 2.67 in the control group. There was no statistically significant difference in treatment status of ibuprofen vs. placebo (p‐value (p.) 0.93), though there was a significant decrease in the measured VAS scores over time (0 minutes to 120 minutes, p.0.031) in both ibuprofen and placebo groups. A statistically significant and clinically important decrease in average VAS scores were seen in both placebo and ibuprofen groups (55% and 60%, respectively). There was no difference in time needed to achieve a clinically significant reduction in pain between groups. The sample size of this study may be inadequate to fully assess the analgesic efficacy of IV ibuprofen for biliary colic. In the analysis group (n=18) no significant difference in treatment status of ibuprofen vs. placebo was seen, however there was a statistically and clinically significant decrease in pain in both groups. Two potential confounding factors may have affected the trial’s results: administration of standard‐of‐care IV morphine following initial triage assessment, and the inherent episodic and self‐limited nature of biliary colic.