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Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Active Comparator | Ketorolac 30mg IVSS |
|
| Metoclopramide | Active Comparator | metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score | Baseline, 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Scores | 24 hours after the emergency department visit, patients were asked, "The next time you come to the Er with this type of headache, do you want to receive the same medication?" Affirmative answers are tabulated here. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 23567060 | Derived | Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6. |
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Patients were recruited from one emergency department (ED) in the Bronx, NY
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac | Ketorolac 30 mg, administered intravenously over 15 minutes |
| FG001 | Metoclopramide | metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
|
| ||||||||||||||||||
| Emergency Department Portion |
| |||||||||||||||||||
| 24 Hour Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | Ketorolac 30 mg, administered intravenously over 15 minutes |
| BG001 | Metoclopramide | metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Pain Score | At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score | 3 randomized patients were not included in this analysis. During the ED visit, these patients were diagnosed with intracranial hemorrhage, brain abscess, and malaria and therefore did not truly have a primary headache disorder. Including these patients, 123 were randomized. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 60 minutes |
|
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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 | Ketorolac | Ketorolac 30 mg, administered intravenously over 15 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman, MD | Montefiore Medical Center, Albert Einstein College of Medicine | 718-920-6626 | BEFRIEDM@montefiore.org |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Ketorolac | Drug | ketorolac 30mg IVSS |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes |
|
|
| Secondary | Satisfaction Scores | 24 hours after the emergency department visit, patients were asked, "The next time you come to the Er with this type of headache, do you want to receive the same medication?" Affirmative answers are tabulated here. | 3 patients in each group were lost to follow-up. All others are tabulated here. | Posted | Number | participants | 24 hours |
|
|
|
| 0 |
| 60 |
| 14 |
| 60 |
| EG001 | Metoclopramide | metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes | 0 | 60 | 12 | 60 |
| Akathisia | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| 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 |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |