Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
This placebo-controlled trial (n=56) will investigate the efficacy and safety of high-dose intravenous ketamine infusion in treating Chronic Daily Headaches (CDH) syndrome.
Details
Multicentre, randomised, double-blind, placebo-controlled parallel trial at two Canadian chronic pain centres comparing high-dose IV ketamine versus saline in participants with chronic daily headache.
Active treatment is a 1 mg/kg IV bolus followed by an infusion of 1 mg/kg/hour (6 hours) with sedation (midazolam), antiemetic and prophylactic measures; placebo arm receives volume-matched saline with identical adjunct medications to preserve blinding.
Outcomes include headache frequency and intensity, mood, activity and sleep (actigraphy), quality of life and safety assessed acutely and at 1, 2 and 3 months post-infusion using validated questionnaires and wearable devices.