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Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide | Experimental | Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | Intravenous medication drip |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Headache Relief | 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. | 2 hours thru 48 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Post Concussion Symptoms Assessed by Post-concussive Symptom Scale | 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. | 7 days |
| Number of Participants Satisfied With Medication; Assessed by Self-evaluation |
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Inclusion Criteria:
Exclusion Criteria:
Per patient
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metoclopramide | Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metoclopramide | Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip |
| 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 | Number of Participants With Sustained Headache Relief | 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. | Posted | Count of Participants | Participants | 2 hours thru 48 hours after treatment |
|
|
Data on adverse events was collected every two hours while in the Emergency Department and then by telephone 48 hours after discharge
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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 administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip |
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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 W. Friedman, MD | Montefiore Health | 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 | Feb 16, 2017 | Jun 18, 2018 | Prot_SAP_000.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 |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Diphenhydramine | Drug | Intravenous medication drip |
|
|
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?" |
| 48 hours after treatment |
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Post Concussion Symptoms Assessed by Post-concussive Symptom Scale | 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 patients were lost to followup | Posted | Mean | Standard Deviation | units on a scale | 7 days |
|
|
|
| Secondary | Number of Participants Satisfied With Medication; Assessed by Self-evaluation | 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?" | 2 patients did not provide an answer to this question | Posted | Count of Participants | Participants | 48 hours after treatment |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 2 |
| 21 |
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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 |