Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial
Recruitment status was: Recruiting
|First Submitted Date ICMJE||October 7, 2005|
|First Posted Date ICMJE||October 12, 2005|
|Last Update Posted Date||December 5, 2006|
|Start Date ICMJE||May 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00237705 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial|
|Official Title ICMJE||Not Provided|
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.
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: metoclopramide|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||19 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00237705|
|Other Study ID Numbers ICMJE||CO4-0025|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Vancouver General Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||Vancouver General Hospital|
|Verification Date||December 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP