Metoclopramide for Post-Traumatic Headache. A Pilot Study

Post-Traumatic Headache Clinical Trial

Official title:

Metoclopramide for Post-Traumatic Headache. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056352
• Other study ID #: 2017-7511
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2017
• Est. completion date: August 15, 2017

Study information

• Verified date: July 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 15, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache

Intervention

Drug:
• Metoclopramide
Intravenous medication drip
• Diphenhydramine
Intravenous medication drip

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours thru 48 hours after treatment
Secondary	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.	7 days
Secondary	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?"	48 hours after treatment