Recruiting

Metoclopramide

Sponsor:

Vancouver General Hospital

Code:

NCT00237705

Conditions

Post Concussive Headache

Post Concussive Syndrome

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

metoclopramide

Study Details

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.

Conditions

Post Concussive Headache

Post Concussive Syndrome

Study ID

NCT00237705

Start date

May, 2004

Status verified date

Dec, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Only patients who meet the following inclusion criteria will be recruited:

1. History of blunt head trauma within preceding 24 hours.
2. Immediate and transient post traumatic impairment of neurological functions defined as alteration of consciousness, amnesia, disorientation, disturbance of vision or equilibrium (10).
3. Onset of headache within one hour of trauma.

Exclusion Criteria:

  • Patients with any of the following exclusion criteria will not be enrolled:

1. Age less than or equal to 19 years.
2. Known or suspected pregnancy.
3. Known hypersensitivity or intolerance to metoclopramide.
4. Inability to give informed consent.
5. Known gastrointestinal hemorrhage, perforation or obstruction.
6. Known seizure disorder.
7. Known pheochromocytoma.
8. Concurrent significant CNS depression due to drugs or alcohol.
9. Concurrent treatment for psychiatric illness.
10. 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

Study Design

Enrollment

40 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

metoclopramide

Primary outcome measure

  • 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. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Jan Buchanon

604 875-4205jan.buchanon@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

David W Harrison, MD

604 875-4033david.harrison@vch.ca

Principal Investigator:

David W Harrison, MD

More Information

Sponsor

Vancouver General Hospital

Last update posted

Dec 5, 2006

Last verified

Dec, 2006

Keywords

  • Headache
  • Concussion
  • Post concussive syndrome
  • Head trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver General Hospital on 2006-12-05.