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 hyoscyamine sulfate in combination with ketorolac tromethamine for the reduction of pain in emergency department patients with ureteral colic.

METHODS: We conducted a prospective, randomized, double-blind study at 2 EDs with residency programs in emergency medicine. Patients were at least 18 years old and presented to the ED with an initial history and physical examination consistent with ureteral colic. Patients received a single intravenous dose of 30 mg of ketorolac tromethamine given over a 1-minute period with 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 dose of meperidine could be administered for rescue. All other treatments including intravenous fluids and antiemetics were standardized. The main study outcome was change in visual analog scale pain score from baseline to 30 minutes.

RESULTS: Seventy-two patients were evaluated for inclusion. Thirteen patients who had self-administered pain medications within 4 hours of presentation were excluded before randomization. Sixteen patients who did not have a renal calculus confirmed by either intravenous urogram or helical computed tomography were also excluded from efficacy analysis. There did not appear to be any clinically important differences in the baseline characteristics between the 2 groups. The repeated-measures analysis of the remaining 43 patients showed no clinically important difference in pain score using the visual analog scale at any time point. There were no clinically important differences between the 2 study groups for amount of rescue meperidine administered 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 was no clinically important difference in change of pain scores at 30 minutes in patients with ureteral colic receiving supplemental hyoscyamine sulfate.