A DOUBLE‐BLINDED RANDOMIZED TRIAL OF IV IBUPROFEN AND MORPHINE COMBINATION THERAPY IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT WITH RENAL COLIC

Abstract

Renal stones (or “calculi”) are a relatively common condition, affecting up to 12 percent of people during their lifetime. Typical presentation of renal calculi is acute, intermittent flank pain, termed “renal colic”, which may radiate to the groin. Pain may be accompanied by hematuria, nausea, or vomiting.1 Acute renal colic is a common cause for presentation to the Emergency Department, accounting for an estimated 1 million emergency room visits annually in the United States.2 The severe pain associated with renal calculi requires immediate analgesia, and effective analgesia is associated with improved functional capacity after drug administration.3 In this trial, we compare the efficacy of IV ketorolac vs. IV ibuprofen for pain control in patients with renal colic in a three‐armed double‐blind prospective trial. Patients were randomized to one of three treatment groups, receiving parenteral infusions of either IV ibuprofen + morphine, IV ketorolac + morphine, or morphine monotherapy. Outcome of drug administration was measured by patients’ self‐assessment of pain on a verbal scale at 15 mins, 30 mins, 60 min, and 120 min after drug administration. We hypothesized that IV ibuprofen would provide effective, non‐opioid pain relief in the emergency setting and might have a lower incidence of adverse effects than ketorolac. Need for rescue analgesia (with 4 mg morphine) was observed as an indirect measure of analgesic efficacy. A total of 11 patients completed the study. There was no significant difference in area under the curve of pain score in any of the three treatment arms (p>0.4). The ibuprofen group demonstrated consistent improvement in pain over the course of 120 min of study, with 100% of the patients in that arm demonstrating downtrending pain scores. Though the sample size was too small to identify a statistically significant difference in need for rescue medication, there was a trend toward increased opioid in the ibuprofen group, with 50% of those participants receiving rescue analgesia with morphine. The sample size of this pilot study is inadequate to fully assess the analgesic efficacy of IV ibuprofen for renal colic. A trend toward improved pain control in the ibuprofen group was observed, with 100% of the patients in the ibuprofen arm reporting decreased pain after 120 minutes (as compared to 66% in the ketorolac arm and 75% in the placebo arm). Further study of efficacy and need for rescue analgesia is warranted.