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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Vancouver General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vancouver General Hospital
ClinicalTrials.gov Identifier:
NCT00237705
First received: October 7, 2005
Last updated: December 4, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention
Post Concussive Headache
Post Concussive Syndrome
Drug: metoclopramide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vancouver General Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: May 2004
Detailed Description:

PURPOSE AND OBJECTIVES The primary objective of this study is to prospectively evaluate the effect of metoclopramide in ED patients with minor head injury. The primary hypothesis is that the administration of intravenous metoclopramide will be effective in relieving the symptoms of acute post traumatic headache in ED patients with minor head injury.

The secondary hypothesis is that the administration of intravenous metoclopramide will also be effective in reducing the incidence of chronic post-concussive syndrome in ED patients with minor head injury. The research question is "Does the administration of intravenous metoclopramide at a dose of 10 or 20 mg to adult ED patients experiencing headache following a minor head injury result in a significant decrease in pain severity as measured on a 10cm visual analogue scale, as compared to placebo?"

RESEARCH METHODOLOGY This is a prospective, double-blind, randomized, placebo-controlled trial.

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 such as alteration of consciousness, amnesia, disorientation, or disturbance of vision or equilibrium.
  3. Onset of headache within one hour of trauma.
  4. Significant intra-cranial injury excluded by CT scan or clinical assessment.

Exclusion criteria will include age less than or equal to 16 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, or concurrent treatment for psychiatric illness.

Patients will be randomized and asked to grade their headache pain severity on a 10-cm non-hatched visual analog scale (VAS) before the administration of the study drugs. They will then receive either 10 mg (2ml) of metoclopramide or 2 ml of saline placebo. After 15 minutes they will again complete the VAS. If their headache is not satisfactorily relieved they will be offered a second dose of study drug and the VAS will be completed again 30 minutes later. Patients will be contacted 1, 4 and 8 weeks later in order to complete a telephone questionnaire to assess for PCS symptoms.

The primary comparison will be between the proportion of patients achieving significant pain relief in each of the two study arms and a difference of 20% of greater in these proportions will be considered clinically significant. A t-test of two proportions will be used and p less than or equal to 0.05 will be considered statistically significant. Secondary outcomes will be evaluated for hypothesis generating purposes using appropriate parametric and non-parametric statistics with corrections for multiple comparisons as needed.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237705

Contacts
Contact: Jan Buchanon 604 875-4205 jan.buchanon@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: David W Harrison, MD    604 875-4033    david.harrison@vch.ca   
Principal Investigator: David W Harrison, MD         
Sponsors and Collaborators
Vancouver General Hospital
Investigators
Principal Investigator: David W Harrison, MD University of British Columbia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00237705     History of Changes
Other Study ID Numbers: CO4-0025
Study First Received: October 7, 2005
Last Updated: December 4, 2006
Health Authority: Canada: Health Canada

Keywords provided by Vancouver General Hospital:
Headache
Concussion
Post concussive syndrome
Head trauma

Additional relevant MeSH terms:
Brain Concussion
Headache
Post-Concussion Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014