Metoclopramide for Post-Traumatic Headache. A Pilot Study

Phase 1

Completed

• Conditions: Post-Traumatic Headache
• Interventions: Drug: Metoclopramide; Drug: Diphenhydramine

• Registration Number: NCT03056352
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-17
• Study Start: 2017-03-01
• Primary Completion: 2017-07-20
• Study Completion: 2017-08-15
• Results First Submitted: 2018-05-08
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Results First Posted: 2018-07-31
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metoclopramide	Metoclopramide	Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
Metoclopramide	Diphenhydramine	Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Headache Relief	2 hours thru 48 hours after treatment	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

Name	Time	Method
Number of Participants Satisfied With Medication; Assessed by Self-evaluation	48 hours after treatment	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?"
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale	7 days	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.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States