Sublingual hyoscyamine sulfate in combination with ketorolac tromethamine for ureteral colic: A randomized, double-blind, controlled trial

Study objective: We evaluate the safety and efficacy of a single dose of hy oscyamine sulfate in combination with ketorolac tromethamine for the reduct ion of pain in emergency department patients with ureteral colic. Methods: We conducted a prospective, randomized, double-blind study at 2 ED s with residency programs in emergency medicine. Patients were at least 18 years old and presented to the ED with an initial history and physical exam ination consistent with ureteral colic. Patients received a single intraven ous dose of 30 mg of ketorolac tromethamine given over a 1-minute period wi th either a single sublingual dose of 0.125 mg of hyoscyamine sulfate or a placebo. If inadequate analgesia was noted after 30 minutes, a standard dos e of meperidine could be administered for rescue. All other treatments incl uding intravenous fluids and antiemetics were standardized. The main study outcome was change in Visual analog scale pain score from baseline to 30 mi nutes. Results: Seventy-two patients were evaluated for inclusion. Thirteen patien ts who had self-administered pain medications within 4 hours of presentatio n were excluded before randomization. Sixteen patients who did not have a r enal calculus confirmed by either intravenous urogram or helical computed t omography were also excluded from efficacy analysis. There did not appear t o be any clinically important differences in the baseline characteristics b etween the 2 groups. The repeated-measures analysis of the remaining 43 pat ients showed no clinically important difference in pain scare using the vis ual analog sea le at any time point. There were no clinically important dif ferences between the 2 study groups for amount of rescue meperidine adminis tered or end-of-study global satisfaction scores. Conclusion: Hyoscyamine sulfate did not provide any additional pain relief from ureteral colic when administered with ketorolac tromethamine. There wa s no clinically important difference in change of pain scores at 30 minutes in patients with ureteral colic receiving supplemental hyoscyamine sulfate .