Metoclopramide for Post-Traumatic Headache. A Pilot Study
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Metoclopramide Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes |
Drug: Metoclopramide
Intravenous medication drip
Other Names:
Drug: Diphenhydramine
Intravenous medication drip
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
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.- 2017-7511
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
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%
|
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)
|
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
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 |
befriedm@montefiore.org |
- 2017-7511