This randomised, double-blind clinical trial (n=0, terminated) aimed to compare the effectiveness of ketamine (21mg/70kg) to prochlorperazine (Compazine) in treating benign headaches in the Emergency Department.
Subjects were randomised into two groups: Group 1 received standard treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, while Group 2 received Ketamine 0.3 mg/kg along with ondansetron 4 mg IV.
Subjects were monitored for vital signs and headache severity at 15, 30, 45, and 60 minutes post-intervention. At 24-48 hours post-intervention, subjects were contacted to assess pain levels and satisfaction with migraine pain management.
The study was conducted at the Mike O’Callaghan Military Hospital. Eligible participants were aged 18 to 65 years and presented to the ED with a headache. Exclusion criteria included pregnancy, breastfeeding, head trauma within the previous two weeks, and known allergies to study medications. The primary outcome measure was the pain score measured on a Visual Analogue Scale at various time points post-intervention. The study began in August 2016 and was completed in May 2017, with a total enrollment of 5 participants.
Trial Details
Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at 15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At 24-48 hours post intervention we will contact subjects and assess their pain and assess their satisfaction with their migraine pain management as part of this study. Subjects' participation will last up to 48 hours post headache.NCT Number NCT02735343
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