Propofol Injection for Daily Headache
Hypothesis A single subanesthetic dose of propofol will result in improved pain and quality of life for the next 30 days in persons with chronic daily headache (CDH)
Specific objectives To measure the effect of a single infusion of propofol at 40 mcg / kg / minute over 60 mins on headache-related quality of life (measured by the Headache Disability Index) and on headache severity (measured by the Headache Index) in subjects with chronic daily headache over 30 days45-47
|Chronic Headache Analgesic Rebound Headache Chronic Daily Headache Headache, Intractable||Drug: Propofol||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
|Official Title:||The Effect of Single-dose Propofol Injection on Pain and Quality of Life in Chronic Daily Headache: a Randomized Double-blind Controlled Trial|
- Headache Disability Index and the Headache Index
- The baseline Headache Index is the mean of all 28 NRS pain scores (four measures daily for seven days) and the post-treatment Headache Index is the mean of all 120 NRS pain scores (four measures daily for thirty days)
- Number of days with a headache of at least moderate severity defined as pain at least 5 on the Numerical Rating Scale (NRS).
- Peak daily headache severity according to the NRS.
- Analgesic medication consumption will be measured in terms of morphine equivalents of narcotic medication and number of tablets /doses of acetaminophen / non-steroidal anti-inflammatory (NSAID) containing analgesics.53
- Visits to the Emergency Room for headache treatment.
- Sedation and nausea scores in the treatment and placebo groups.
- Ability of participants in each of the groups to correctly guess their treatment assignment.
- Adverse effects related to the infusion
|Study Start Date:||September 2004|
|Study Completion Date:||November 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228267
|Multidisciplinary Pain Centre, Univ. Alta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Mark K Simmonds, MD||University of Alberta|