Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Concussion is defined as any temporary disturbance in brain function following a blow to the head. It may not involve a loss of consciousness and usually results in a post concussive headache (PCH) immediately after the injury. Between 30 and 50 percent of patients with concussion will develop postconcussive syndrome (PCS) consisting of symptoms such as headache, and a variety of other debilitating symptoms lasting several weeks to months. The objective of this study is to determine if metoclopramide, a drug commonly used in the treatment of migraine headache, will be effective in relieving PCH and in preventing PCS. Eligible patients will have a history of a concussion resulting in headache within the past 24 hours. Patients will rate their pain on a standard scale before and after being treated with one or two intravenous doses of either metoclopramide or saltwater placebo. They will be contacted by telephone 1, 4 and 8 weeks later in order to determine if they have developed the postconcussive syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedDecember 5, 2006
December 1, 2006
October 7, 2005
December 4, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome of acute PCH relief will be determined by measuring the difference between VAS score at baseline and after the last dose of study drug.
Secondary Outcomes (1)
The secondary outcome of PCS will be measured by telephone questionnaire using the Rivermead Post Concussion Symptoms Questionnaire at 1, 4 and 8 weeks after injury
Interventions
Eligibility Criteria
You may qualify if:
- History of blunt head trauma within preceding 24 hours.
- Immediate and transient post traumatic impairment of neurological functions defined as alteration of consciousness, amnesia, disorientation, disturbance of vision or equilibrium (10).
- Onset of headache within one hour of trauma.
You may not qualify if:
- Age less than or equal to 19 years.
- Known or suspected pregnancy.
- Known hypersensitivity or intolerance to metoclopramide.
- Inability to give informed consent.
- Known gastrointestinal hemorrhage, perforation or obstruction.
- Known seizure disorder.
- Known pheochromocytoma.
- Concurrent significant CNS depression due to drugs or alcohol.
- Concurrent treatment for psychiatric illness.
- Any acute brain injury on CT scan (if performed) as defined by any radiographic finding which would normally require admission to hospital and neurological follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David W Harrison, MD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
May 1, 2004
Last Updated
December 5, 2006
Record last verified: 2006-12