Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
Status:
Not yet recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
Chronic daily headaches (CDH) poses a significant burden on patients, healthcare systems and
the society. Intravenous (IV) ketamine infusion, an intervention that is widely available and
scalable, can treat CDH by reversing receptor-mediated sensitization. This study is a
multicenter, placebo-controlled, parallel group randomized trial with blinding of
participants and observers with the goal of comprehensively assessing the effect of high-dose
IV ketamine infusion (1 mg.kg-1.h-1 for six hours) on the frequency and intensity of
headaches, mood, activity, sleep, quality of life and safety of ketamine for three months
after the interventions. Use of validated questionnaires, wearable technology, a research
team that includes investigators with expertise in studying ketamine and in evaluating
treatments for CDH and pain syndromes are some of the unique features of this project.
Our study aims to prospectively assess the efficacy and safety of high-dose intravenous
ketamine infusions compared to saline infusions in participants with CDH syndrome.