Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vancouver General Hospital
• Treatments: Metoclopramide

Criteria

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