Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches

PHASE3RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

October 1, 2025

Study Completion Date

February 1, 2026

Conditions
Chronic Daily Headache
Interventions
DRUG

Ketamine

Bolus of IV Ketamine 1 mg.kg-1 (= 0.1 ml.kg-1) followed by Infusion of Ketamine 1 mg.kg-1.hour-1 (= 0.5 mL.kg-1.hour-1) for 6 hours. All patients will receive IV midazolam 0.04 mg.kg-1 (maximum 3 mg) and subsequently 0.01-0.02 mg.kg-1 every hour to keep participants in a sedated but arousable state (Ramsay Sedation Scale score 3 or 4) to blind the participants and assessors to group allocation. Ondansetron 8 mg and 8 mg of dexamethasone will be administered to prevent nausea, 5000 units of heparin will be given subcutaneously to prevent thrombo-embolic events.

OTHER

0.9% Saline

Bolus of IV Saline 0.9% of 0.1 ml.kg-1 followed by Infusion of Saline 0.9% of 0.5 mL.kg-1.hour-1 for 6 hours. All patients will receive IV midazolam 0.04 mg.kg-1 (maximum 3 mg) and subsequently 0.01-0.02 mg.kg-1 every hour to keep participants in a sedated but arousable state (Ramsay Sedation Scale score 3 or 4) to blind the participants and assessors to group allocation. Ondansetron 8 mg and 8 mg of dexamethasone will be administered to prevent nausea, 5000 units of heparin will be given subcutaneously to prevent thrombo-embolic events.

Trial Locations (2)

M5S 1B2

NOT_YET_RECRUITING

Women's College Hospital, Toronto

M5T 2S8

RECRUITING

Toronto Western Hospital, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Canadian Pain Society

OTHER

collaborator

Pfizer

INDUSTRY

lead

University Health Network, Toronto

OTHER

NCT05306899 - Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches | Biotech Hunter | Biotech Hunter