Metoclopramide for Post Traumatic Headache

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03220958
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Headache	Drug: Metoclopramide; Drug: Diphenhydramine; Drug: Normal saline	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metoclopramide Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip	Drug: Metoclopramide; Metoclopramide 20mg; Drug: Diphenhydramine; Diphenhydramine 25mg; Drug: Normal saline; 100ml normal saline
Placebo Comparator: Placebo Normal saline, administered as an intravenous drip	Drug: Normal saline; 100ml normal saline

Outcome Measures

Primary Outcome Measures

1. 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable [1 hour after medication administration]

   Improvement in this 0 to 10 verbal rating scale

Secondary Outcome Measures

1. Sustained Headache Relief [48 hours after medication administration]

   Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe

2. Headache Days [7 days after ED visit]

   Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Included patients will be adults who meet International Classification of Headache

Disorders criteria for acute post-traumatic headache. These are as follows:

• 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.

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 MAO inhibitors, and use of anti-rejection transplant medications.

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)

• Study Protocol and Statistical Analysis Plan - Jul 11, 2018

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Associate Professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03220958
• Other Study ID Numbers: 2017-7898
• First Posted: Jul 18, 2017
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• 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.: Yes
• Additional relevant MeSH terms: Post-Traumatic Headache; Headache; Diphenhydramine; Promethazine; Metoclopramide

Study Results

Participant Flow

Arm/Group Title	Metoclopramide	Placebo
Arm/Group Description	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Period Title: Overall Study
STARTED	81	79
COMPLETED	81	79
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Metoclopramide	Placebo	Total
Arm/Group Description	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline	Total of all reporting groups
Overall Participants	81	79	160
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (16)	46 (17)	45 (16)
Sex: Female, Male (Count of Participants)
Female	51 63%	56 70.9%	107 66.9%
Male	30 37%	23 29.1%	53 33.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	81 100%	79 100%	160 100%
Baseline pain intensity, as measured on a 0-10 scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.3 (1.6)	8.3 (1.5)	8.3 (1.6)

Outcome Measures

1. Primary Outcome

Title	0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
Description	Improvement in this 0 to 10 verbal rating scale
Time Frame	1 hour after medication administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metoclopramide	Placebo
Arm/Group Description	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Measure Participants	81	79
Mean (Standard Deviation) [units on a scale]	5.2 (2.3)	3.8 (2.6)

2. Secondary Outcome

Title	Sustained Headache Relief
Description	Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe
Time Frame	48 hours after medication administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metoclopramide	Placebo
Arm/Group Description	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Measure Participants	78	76
Count of Participants [Participants]	24 29.6%	18 22.8%

3. Secondary Outcome

Title	Headache Days
Description	Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities
Time Frame	7 days after ED visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metoclopramide	Placebo
Arm/Group Description	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Measure Participants	76	71
Mean (Standard Deviation) [days]	3.3 (1.6)	3.3 (1.6)

Adverse Events

Time Frame	48 hours
Arm/Group Title	Metoclopramide		Placebo
Arm/Group Description	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline		Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
All Cause Mortality
	Metoclopramide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/79 (0%)
Serious Adverse Events
	Metoclopramide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/79 (0%)
Other (Not Including Serious) Adverse Events
	Metoclopramide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/81 (43.2%)		22/79 (27.8%)
Gastrointestinal disorders
Diarrhea	2/81 (2.5%)		1/79 (1.3%)
Investigations
Various other	2/81 (2.5%)		7/79 (8.9%)
Nervous system disorders
Drowsiness	15/81 (18.5%)	15	8/79 (10.1%)	8
Akathisia	5/81 (6.2%)		0/79 (0%)
Dizziness	4/81 (4.9%)		1/79 (1.3%)
Post-concussive syndrome	7/81 (8.6%)		5/79 (6.3%)

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.