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

Primary Purpose

Post Concussive Headache, Post Concussive Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
metoclopramide
Sponsored by
Vancouver General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Concussive Headache focused on measuring Headache, Concussion, Post concussive syndrome, Head trauma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Only patients who meet the following inclusion criteria will be recruited: 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. Exclusion Criteria: Patients with any of the following exclusion criteria will not be enrolled: 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

Sites / Locations

  • Vancouver General HospitalRecruiting

Outcomes

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

Full Information

First Posted
October 7, 2005
Last Updated
December 4, 2006
Sponsor
Vancouver General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00237705
Brief Title
Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Vancouver General Hospital

4. Oversight

5. Study Description

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.
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: History of blunt head trauma within preceding 24 hours Immediate and transient post traumatic impairment of neurological functions such as alteration of consciousness, amnesia, disorientation, or disturbance of vision or equilibrium. Onset of headache within one hour of trauma. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Concussive Headache, Post Concussive Syndrome
Keywords
Headache, Concussion, Post concussive syndrome, Head trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
metoclopramide
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Only patients who meet the following inclusion criteria will be recruited: 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. Exclusion Criteria: Patients with any of the following exclusion criteria will not be enrolled: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Buchanon
Phone
604 875-4205
Email
jan.buchanon@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Harrison, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David W Harrison, MD
Phone
604 875-4033
Email
david.harrison@vch.ca
First Name & Middle Initial & Last Name & Degree
David W Harrison, MD

12. IPD Sharing Statement

Learn more about this trial

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

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