Back to resultsMetoclopramide for Post-Traumatic Headache. A Pilot Study
Primary Purpose
Post-Traumatic Headache
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metoclopramide
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Headache
Eligibility Criteria
Inclusion Criteria:
- Traumatic injury to the head has occurred
- Headache has developed within 7 days of injury to the head
- Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
- The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
- The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
Exclusion Criteria:
- Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metoclopramide
Arm Description
Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
Outcomes
Primary Outcome Measures
Number of Participants With Sustained Headache Relief
Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.
Secondary Outcome Measures
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.
Number of Participants Satisfied With Medication; Assessed by Self-evaluation
Satisfaction is measured by a positive response to the question "Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"
Full Information
NCT ID
NCT03056352
First Posted
February 14, 2017
Last Updated
July 2, 2018
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03056352
Brief Title
Metoclopramide for Post-Traumatic Headache. A Pilot Study
Official Title
Metoclopramide for Post-Traumatic Headache. A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metoclopramide
Arm Type
Experimental
Arm Description
Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Reglan
Intervention Description
Intravenous medication drip
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Intervention Description
Intravenous medication drip
Primary Outcome Measure Information:
Title
Number of Participants With Sustained Headache Relief
Description
Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.
Time Frame
2 hours thru 48 hours after treatment
Secondary Outcome Measure Information:
Title
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
Description
The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.
Time Frame
7 days
Title
Number of Participants Satisfied With Medication; Assessed by Self-evaluation
Description
Satisfaction is measured by a positive response to the question "Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"
Time Frame
48 hours after treatment
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Per patient
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Traumatic injury to the head has occurred
Headache has developed within 7 days of injury to the head
Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
Exclusion Criteria:
Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metoclopramide for Post-Traumatic Headache. A Pilot Study
We'll reach out to this number within 24 hrs