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Three doses of intravenous (i.v.) ondansetron, 1 mg, 4 mg, and 8 mg, were compared to placebo for their antiemetic effect and safety. The drugs or placebo were administered in a double-blind manner, prophylactically to 589 women undergoing elective outpatient surgical procedures under nitrous oxide opioid-based general endotracheal anesthesia. In the postanesthesia care unit, the number of emetic episodes, periodic assessments of nausea severity using an 11-point scale (0 = no nausea; 10 = worst nausea), vital signs, and adverse events were collected by an independent observer for 2 h. Upon discharge, identical information, with the exception of vital signs, was collected from the patients' diary and via phone call. One pre- and two poststudy blood specimens for hematology and chemistries were evaluated. During the initial 2 h, patients receiving any dose of ondansetron had significantly better complete response rates (no emesis) than those receiving placebo. Over the 24-h study period, patients who received either 4 mg or 8 mg ondansetron continued to have significantly greater complete response rates. Adverse events were minor, and ondansetron-treated patients had profiles similar to those of the placebo. Heart rate, blood pressure, respiratory rate, and laboratory safety variables were not different among the groups. Ondansetron did not prolong awakening time. This study indicates that ondansetron is a safe and effective prophylactic antiemetic for women who have outpatient surgery under nitrous oxide opioid-based general anesthesia.

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Objective We compared metoclopramide 20 mg IV, combined with diphenhydramine 25 mg IV, to ketorolac 30 mg IV in adults with tension-type headache and all non-migraine, non-cluster recurrent headaches. Methods In this ED-based randomized, double-blind study, we enrolled adults with non-migraine, non-cluster recurrent headaches. Patients with tension-type headache were a subgroup of special interest. Our primary outcome was a comparison of the improvement in pain score between baseline and one hour later, assessed on a 0 to 10 verbal scale. We defined a between-group difference of 2.0 as the minimum clinically significant difference. Secondary endpoints included: 1) need for rescue medication in the ED; 2) achieving headache freedom in the ED and sustaining it for 24 hours; and 3) patient’s desire to receive the same medication again. Results We included 120 patients in the analysis. The metoclopramide/diphenhydramine arm improved by a median of 5 (IQR 3,7) scale units while the ketorolac arm improved by a median of 3 (IQR 2,6) (95%CI for difference: 0, 3). Metoclopramide + diphenhydramine were superior to ketorolac for all three secondary outcomes: the number needed to treat for not requiring ED rescue medication was 3 (95%CI: 2, 6), for sustained headache freedom 6 (95%CI: 3, 20), and for wish to receive the same medication again 7 (95%CI: 4, 65). Tension-type headache subgroup results were similar. Conclusions For adults who presented to an ED with tension-type headache or with non-migraine, non-cluster recurrent headache, IV metoclopramide + diphenhydramine provided more headache relief than IV ketorolac.