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Trial record 41 of 450 for:    diphenhydramine

Metoclopramide for Post-Traumatic Headache. A Pilot Study

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ClinicalTrials.gov Identifier: NCT03056352
Recruitment Status : Completed
First Posted : February 17, 2017
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 17, 2017
Results First Submitted Date  ICMJE May 8, 2018
Results First Posted Date  ICMJE July 31, 2018
Last Update Posted Date July 31, 2018
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date July 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Sustained headache relief [ Time Frame: 48 hours ]
Headachelevel of mild or none achieved in the emergency department and maintained for 48 hours
Change History Complete list of historical versions of study NCT03056352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • 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.
  • 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?"
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Post concussion symptom scale [ Time Frame: 48 hours and 7 days ]
    This instrument assesses typical post-concussion symptoms
  • Satisfaction with medication [ Time Frame: 48 hours ]
    Would you want to receive the same medication during a subsequent visit for post-traumatic headache?
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metoclopramide for Post-Traumatic Headache. A Pilot Study
Official Title  ICMJE Metoclopramide for Post-Traumatic Headache. A Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Headache
Intervention  ICMJE
  • Drug: Metoclopramide
    Intravenous medication drip
    Other Name: Reglan
  • Drug: Diphenhydramine
    Intravenous medication drip
    Other Name: Benadryl
Study Arms  ICMJE Experimental: Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
Interventions:
  • Drug: Metoclopramide
  • Drug: Diphenhydramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2018)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
20
Actual Study Completion Date  ICMJE August 15, 2017
Actual Primary Completion Date July 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Per patient
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056352
Other Study ID Numbers  ICMJE 2017-7511
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Benjamin W. Friedman, MD, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP