Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-04-23 @ 11:56 PM
Study NCT ID:
NCT02972502
Status:
TERMINATED
Last Update Posted:
2018-10-23
First Post:
2016-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chelsea.blessing@ohiohealth.com', 'phone': '(513) 461-1772', 'title': 'Chelsea Blessing, PhD', 'organization': 'OhioHealth Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was terminated by the IRB due to PI lapse in required training. Outcomes data reported includes preliminary figures for n=49 patients. Data not collected from 11 patients.'}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'description': 'Study was terminated early. Some information entered for n=49 participants. Data not collected for 11 participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Metoclopramide (Reglan)', 'description': 'Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nMetoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Haloperidol (Haldol)', 'description': 'Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nHaloperidol: Patients receive 2.5 mg of IV haloperidol.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Score According to the Numeric Pain Intensity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide (Reglan)', 'description': 'Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nMetoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}, {'id': 'OG001', 'title': 'Haloperidol (Haldol)', 'description': 'Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nHaloperidol: Patients receive 2.5 mg of IV haloperidol.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.86', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-5.13', 'spread': '2.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)', 'description': 'Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.'}, {'type': 'SECONDARY', 'title': 'Need for Additional Medications Used in the Emergency Department (ED)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide (Reglan)', 'description': 'Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nMetoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}, {'id': 'OG001', 'title': 'Haloperidol (Haldol)', 'description': 'Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nHaloperidol: Patients receive 2.5 mg of IV haloperidol.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours post discharge', 'description': 'Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide (Reglan)', 'description': 'Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nMetoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}, {'id': 'OG001', 'title': 'Haloperidol (Haldol)', 'description': 'Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nHaloperidol: Patients receive 2.5 mg of IV haloperidol.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours post discharge', 'description': 'Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metoclopramide (Reglan)', 'description': 'Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nMetoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}, {'id': 'FG001', 'title': 'Haloperidol (Haldol)', 'description': 'Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nHaloperidol: Patients receive 2.5 mg of IV haloperidol.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metoclopramide (Reglan)', 'description': 'Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nMetoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}, {'id': 'BG001', 'title': 'Haloperidol (Haldol)', 'description': 'Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.\n\nHaloperidol: Patients receive 2.5 mg of IV haloperidol.\n\nNormal Saline: All patients receive a 1-liter bolus of normal saline (NS)\n\nDiphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.5', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '36.9', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '35.7', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Somali', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Pain Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.13', 'spread': '1.36', 'groupId': 'BG000'}, {'value': '8.54', 'spread': '1.34', 'groupId': 'BG001'}, {'value': '8.35', 'spread': '1.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Pain Score derived from Numeric Pain Intensity Scale. This scale is a patient-reported numeric measure of pain, from 0 \\[no pain\\] to 10 \\[worst pain imaginable.\\]', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-16', 'size': 148906, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-19T16:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'whyStopped': 'PI lapsed institutional training', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2016-11-07', 'resultsFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-26', 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score According to the Numeric Pain Intensity Scale', 'timeFrame': 'Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)', 'description': 'Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Need for Additional Medications Used in the Emergency Department (ED)', 'timeFrame': '48 hours post discharge', 'description': 'Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge'}, {'measure': 'Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge', 'timeFrame': '48 hours post discharge', 'description': 'Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metoclopramide (Reglan)', 'Haloperidol (Haldol)'], 'conditions': ['Headache, Migraine']}, 'descriptionModule': {'briefSummary': "Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency department (ED).In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain.\n\nBy exploring haloperidol as an option for treatment, the investigators hope to discover a more efficient and effective medication for the treatment of non-traumatic headaches, thereby decreasing a patient's length of stay in the department and decreasing the rate of return visits for continued discomfort from the same headache. This study could lead to the increased usage of haloperidol as a first line agent in the treatment of prolonged headaches presenting to the ED.", 'detailedDescription': 'At this time, choice of medications for the treatment of headaches in the ED is still based on personal and patient preferences because no properly constructed trials have been carried out that would allow identification of a superior agent. Metoclopramide (Reglan) is a common agent used for relief of headaches in the ED. Uncontrolled studies have shown successful relief of migraine with metoclopramide of 75%. Further studies have reported success rate of 67% with IV metoclopramide. In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain. These receptors are relatively abundant in the brainstem nuclei and sympathetic ganglia and nerves, through which they may regulate autonomic visceral, gastrointestinal, and hemodynamic responses frequently associated with migraine. One study, demonstrated that 4 out of 5 patients felt significant relief in pain intensity with the use of haloperidol, even when other medications had failed. Relapses were rare, and several patients reported that haloperidol interrupted the prolonged, intractable migraine spiral they had suffered for days. Furthermore, a case series of six cases of migraine treated with 5mg of haloperidol IV after a 500 to 1000ml bolus of IV fluids reported complete or substantial relief within 25 to 65 minutes and side effects were reported as minimal.\n\nThe investigators hypothesize that Haloperidol is more efficacious than metoclopramide in the treatment of an acute headache or migraine in the ED in regard to a self-reported pain rating scale (Numeric Pain Intensity Scale), need for additional medication, emergency department return rates, and resolution of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who present with a headache or migraine with onset less than or equal to 72 hours\n\nExclusion Criteria:\n\n* Known pregnancy\n* Breast-feeding women\n* Known history of arrhythmias or QT prolongation (450 ms)\n* Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide\n* Subarachnoid hemorrhage\n* Headaches caused by trauma, meningitis\n* Congestive heart failure\n* Parkinson's Disease\n* Dementia\n* Pheochromocytoma\n* History of glaucoma\n* History of seizures\n* Non-English speaking patients"}, 'identificationModule': {'nctId': 'NCT02972502', 'briefTitle': 'Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'OhioHealth'}, 'officialTitle': 'Investigating the Efficacy of Using Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department: A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '13-0078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metoclopramide (Reglan)', 'description': 'Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.', 'interventionNames': ['Drug: Metoclopramide', 'Other: Normal Saline', 'Drug: Diphenhydramine']}, {'type': 'EXPERIMENTAL', 'label': 'Haloperidol (Haldol)', 'description': 'Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.', 'interventionNames': ['Drug: Haloperidol', 'Other: Normal Saline', 'Drug: Diphenhydramine']}], 'interventions': [{'name': 'Metoclopramide', 'type': 'DRUG', 'otherNames': ['Reglan'], 'description': 'Patients receive 10 mg of intravenous (IV) metoclopramide.', 'armGroupLabels': ['Metoclopramide (Reglan)']}, {'name': 'Haloperidol', 'type': 'DRUG', 'otherNames': ['Haldol'], 'description': 'Patients receive 2.5 mg of IV haloperidol.', 'armGroupLabels': ['Haloperidol (Haldol)']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': 'All patients receive a 1-liter bolus of normal saline (NS)', 'armGroupLabels': ['Haloperidol (Haldol)', 'Metoclopramide (Reglan)']}, {'name': 'Diphenhydramine', 'type': 'DRUG', 'otherNames': ['Benadryl'], 'description': 'All patients receive 25 mg of intravenous (IV) diphenhydramine.', 'armGroupLabels': ['Haloperidol (Haldol)', 'Metoclopramide (Reglan)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43228', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'OhioHealth Doctors Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Christopher Lloyd, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attending Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OhioHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Christopher Lloyd', 'investigatorAffiliation': 'OhioHealth'}}}}