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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide | Experimental | Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip |
|
| Placebo | Placebo Comparator | Normal saline, administered as an intravenous drip |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | Metoclopramide 20mg |
| |
| Diphenhydramine |
| Measure | Description | Time Frame |
|---|---|---|
| 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable | Improvement in this 0 to 10 verbal rating scale | 1 hour after medication administration |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Headache Relief | 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 | 48 hours after medication administration |
| Headache Days |
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Inclusion Criteria:
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33762421 | Derived | Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metoclopramide | Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline |
| FG001 | Placebo | Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metoclopramide | Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable | Improvement in this 0 to 10 verbal rating scale | Posted | Mean | Standard Deviation | units on a scale | 1 hour after medication administration |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metoclopramide | Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman | Montefiore | 718-920-6626 | befriedm@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2018 | Nov 8, 2021 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D004155 | Diphenhydramine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Drug |
Diphenhydramine 25mg |
|
| Normal saline | Drug | 100ml normal saline |
|
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 |
| 7 days after ED visit |
Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline pain intensity, as measured on a 0-10 scale | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Sustained Headache Relief | 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 | Posted | Count of Participants | Participants | 48 hours after medication administration |
|
|
|
| Secondary | Headache Days | 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 | Posted | Mean | Standard Deviation | days | 7 days after ED visit |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 35 |
| 81 |
| EG001 | Placebo | Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline | 0 | 79 | 0 | 79 | 22 | 79 |
| Akathisia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Post-concussive syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Various other | Investigations | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |