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No recruitment occurred and PI retired
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Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in the emergency department in comparison to a common migraine treatment regimen of metoclopramide and diphenhydramine.
Investigators conducted a prospective, double-blind, randomized controlled trial in migraine patients who presented to an academic emergency department between June 2013 and November 2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5 mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue medication was given at the treating physician's discretion. Adverse reactions were recorded and electrocardiograms (ECGs) were obtained before and after study medication administration. Follow up phone surveys were performed 72 hours after discharge to assess headache recurrence, adverse effects, and patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haloperidol and Diphenhydramine | Active Comparator | Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1 |
|
| Metoclopramide and Diphenhydramine | Active Comparator | Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol | Drug | 5mg IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores on the visual analog scale | 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea and restlessness scores on the visual analog scales | 20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later |
| Measure | Description | Time Frame |
|---|---|---|
| QT prolongation caused by the administration of Haloperidol | EKGs were performed prior to the administration of study meds and then again at the completion of the study. | 2 hours after administration of Haldol |
Inclusion Criteria:
Migraine Headache must contain the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Gaffigan, MD | United States Naval Medical Center, Portsmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
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| Metoclopramide 10mg | Drug | 10mg IV |
|
|
| Diphenhydramine | Drug | 25mg IV |
|
|
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D009325 | Nausea |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D008787 | Metoclopramide |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| 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 |
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