Metoclopramide for Post-Traumatic Headache. A Pilot Study

Sponsor
Montefiore Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03056352
Collaborator
(none)
21
1
1
5.5
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Metoclopramide for Post-Traumatic Headache. A Pilot Study
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Jul 20, 2017
Actual Study Completion Date :
Aug 15, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metoclopramide

Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes

Drug: Metoclopramide
Intravenous medication drip
Other Names:
  • Reglan
  • Drug: Diphenhydramine
    Intravenous medication drip
    Other Names:
  • Benadryl
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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?"

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montefiore Medical Center Bronx New York United States 10467

    Sponsors and Collaborators

    • Montefiore Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Benjamin W. Friedman, MD, Professor, Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT03056352
    Other Study ID Numbers:
    • 2017-7511
    First Posted:
    Feb 17, 2017
    Last Update Posted:
    Jul 31, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Metoclopramide
    Arm/Group Description Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
    Period Title: Overall Study
    STARTED 21
    COMPLETED 20
    NOT COMPLETED 1

    Baseline Characteristics

    Arm/Group Title Metoclopramide
    Arm/Group Description Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
    Overall Participants 21
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    45
    (18)
    Sex: Female, Male (Count of Participants)
    Female
    16
    76.2%
    Male
    5
    23.8%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (participants) [Number]
    United States
    21
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Metoclopramide
    Arm/Group Description Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
    Measure Participants 20
    Count of Participants [Participants]
    12
    57.1%
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    2 patients were lost to followup
    Arm/Group Title Metoclopramide
    Arm/Group Description Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
    Measure Participants 19
    Mean (Standard Deviation) [units on a scale]
    11.4
    (21.4)
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    2 patients did not provide an answer to this question
    Arm/Group Title Metoclopramide
    Arm/Group Description Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
    Measure Participants 19
    Count of Participants [Participants]
    16
    76.2%

    Adverse Events

    Time Frame Data on adverse events was collected every two hours while in the Emergency Department and then by telephone 48 hours after discharge
    Adverse Event Reporting Description
    Arm/Group Title Metoclopramide
    Arm/Group Description Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
    All Cause Mortality
    Metoclopramide
    Affected / at Risk (%) # Events
    Total 0/21 (0%)
    Serious Adverse Events
    Metoclopramide
    Affected / at Risk (%) # Events
    Total 0/21 (0%)
    Other (Not Including Serious) Adverse Events
    Metoclopramide
    Affected / at Risk (%) # Events
    Total 2/21 (9.5%)
    Nervous system disorders
    Drowsiness 2/21 (9.5%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Benjamin W. Friedman, MD
    Organization Montefiore Health
    Phone 718-920-6626
    Email befriedm@montefiore.org
    Responsible Party:
    Benjamin W. Friedman, MD, Professor, Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT03056352
    Other Study ID Numbers:
    • 2017-7511
    First Posted:
    Feb 17, 2017
    Last Update Posted:
    Jul 31, 2018
    Last Verified:
    Jul 1, 2018