Randomised, triple-blind, parallel Phase III ED trial (n=5) comparing IV ketamine 0.3 mg/kg + ondansetron 4 mg to prochlorperazine 10 mg + diphenhydramine 25 mg for benign headache; terminated.
Randomised, triple-blind, parallel design conducted in the emergency department comparing standard prochlorperazine (10 mg IV) plus diphenhydramine (25 mg IV) versus ketamine 0.3 mg/kg IV with ondansetron 4 mg IV. Participants received a single intravenous treatment and were observed with repeated assessments up to 60 minutes.
Outcomes collected at 15, 30, 45 and 60 minutes included heart rate, blood pressure, and 100-mm VAS measures of headache, nausea, vomiting, anxiety and restlessness; a 24–48 hour follow-up assessed pain and satisfaction with migraine pain management.
Prochlorperazine 10 mg IV + diphenhydramine 25 mg IV (standard ED care).
Prochlorperazine 10 mg IV + diphenhydramine 25 mg IV (standard treatment).
Ketamine 0.3 mg/kg IV + ondansetron 4 mg IV (research arm).
Ondansetron 4 mg IV given with ketamine.