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Completed

NCT Number: NCT03056352

Metoclopramide for Post-Traumatic Headache. A Pilot Study

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

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Key information

Conditions

Post-Traumatic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metoclopramide

Drug

Intravenous medication drip

Other names: Reglan

diphenhydramine

Drug

Intravenous medication drip

Other names: Benadryl

Primary outcomes

  1. Number of Participants With Sustained Headache Relief

    Time frame: 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 outcomes

  1. Post Concussion Symptoms Assessed by Post-concussive Symptom Scale

    Time frame: 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.

  2. Number of Participants Satisfied With Medication; Assessed by Self-evaluation

    Time frame: 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?"

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2017
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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