Administrative information
Title | The efficacy and safety of intravenous ketamine for chronic daily headaches: Trial protocol for a randomized controlled “KetHead” trial |
Primary registry and trial identifying number | ClinicalTrials.gov NCT05306899 |
Other protocol identifier | 21-5523 |
Date of registration in primary registry | April 1, 2022 |
Protocol version | Version 3.0 dated 16Aug2022 |
Funding | Canadian Pain Society and Pfizer Canada |
Author details | Yasmine Hoydonckx MD MSc FIPP Mandeep Singh MBBS MD MSc FRCPC Jamal Kara MSc CCRP Anuj Bhatia MBBS MD PhD FCCPC Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada Ian Gilron MD MSc Department of Anesthesiology and Perioperative Medicine, Queens University, Kingston, Canada James Khan MD MSc FRCPC Department of Anesthesia and Pain Medicine, University of Toronto, Mount Sinai Hospital, Toronto, Ontario, Canada Samer Narouze MD PhD Department of Anesthesia and Pain Medicine, Western Reserve Hospital, Cuyahoga Falls, Ohio, USA Albert Dahan MD PhD Department of Anesthesiology, Leiden University, Leiden, The Netherlands Kathryn Curtis PhD, C. Psych. Comprehensive Integrated Pain Program, University Health Network, Toronto, Canada Xingshan Cao PhD Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada |
Primary sponsor | Department of Anesthesia and Pain Management University Health Network 399 Bathurst Street, 2-McL Toronto, ON M5T 2S8 Tel: (416) 603-5800 ext. 6237 Fax: (416) 603-6494 |
Contact for public queries | Department of Anesthesia and Pain Management Toronto Western Hospital, University Health Network, 399 Bathurst Street Toronto |
Contact for scientific queries | Principal Investigator: Yasmine Hoydonckx MD, MSc, FIPP Toronto Western Hospital, University Health Network 399 Bathurst Street, 2-McL Toronto, ON M5T 2S8 yasmine.hoydonckx@uhn.ca Tel: (416) 603-5800 ext. 6237 Fax: (416) 603-6494 Contact for scientific queries: Jamal Kara MSc, CCRP Trial Coordinator Department of Anesthesia and Pain Management Toronto Western Hospital, University Health Network 399 Bathurst Street, 2-McL Toronto, ON M5T 2S8
Jamal.kara@uhn.ca
kawalpreet.singh@uhnresearch.ca Tel: (416) 603-5800 ext. 6237 Fax: (416) 603-6494 |
Role of sponsor | The sponsor or funders have no role in the trial design, collection, management, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication. |
Introduction
Background and rationale
Rationale
Objectives
Hypothesis
Trial design
Methods
Trial setting
Eligibility criteria
Inclusion criteria: 1. Age 18 years or older 2. CDH diagnosis according to the International Classification of Headache Disorder – 3rd edition [18] 3. Normal liver and kidney function Exclusion criteria: 1. Pregnant or breastfeeding participants 2. Pre-existing renal impairment: stage 4 chronic kidney disease 3. Pre-existing liver impairment, defined as alanine transaminase (ALT) and/or aspartate aminotransferase (AST) greater than two times the upper normal limit, an elevated total bilirubin (TB), an elevated alkaline phosphatase (AP), an elevated international normalized ratio (INR) for prothrombin time, and/or an elevated blood urea nitrogen (BUN) 4. Chronic benzodiazepine or antipsychotic medication use 5. History of a cerebrovascular event 6. Significant and untreated hypertension and severe cardiac decompensation 7. Pheochromocytoma 8. Hyperthyroidism 9. Glaucoma 10. Concomitant use of strong CYP2B6 or CYP2C8 inhibitor 11. Allergy or intolerance to ketamine 12. Any significant cognitive or language barriers that impede participation 13. Use of calcitonin gene-related peptide antagonists in one month or onabotulinum-toxin A in 3 months prior to the trial medication infusion, that is associated with greater than 30% reduction in headache intensity or number of migraine days 14. Active diagnosis of post-traumatic stress disorder 15. Active diagnosis of substance use disorder 16. Daily oral morphine equivalent (OME) of 80 mg or higher |