IV Haloperidol for the Treatment of Headache in the ED
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ClinicalTrials.gov Identifier: NCT02747511 |
Recruitment Status :
Completed
First Posted : April 21, 2016
Last Update Posted : December 12, 2017
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Sponsor:
Western Michigan University School of Medicine
Information provided by (Responsible Party):
Jessica McCoy, Western Michigan University School of Medicine
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Brief Summary:
Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. A total of 150 patients age 13-55 presenting to the emergency department with headache will be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by telephone at 24 hours.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Headache Migraine Disorders | Drug: Haloperidol Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Intravenous Haloperidol for the Treatment of Headache in the Emergency Department |
Study Start Date : | October 2015 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | October 2017 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Migraine
MedlinePlus related topics:
Headache
Arm | Intervention/treatment |
---|---|
Active Comparator: Haloperidol |
Drug: Haloperidol |
Placebo Comparator: Placebo |
Drug: Placebo
Other Name: 0.9% Sodium Chloride |
Primary Outcome Measures :
- >50% reduction in pain per Visual Analog Scale (VAS) [ Time Frame: 90 minute interval ]
Information from the National Library of Medicine

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Ages Eligible for Study: | 13 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Emergency Department patients that complain of headache or migraine
- Males and females age 13-55
- English is primary language
Exclusion Criteria:
- Abnormal blood pressure (>200/100)
- Sudden rapid onsent (normal to worst pain in minutes)
- Fever
- Trauma
- Any history of masses, strokes, head injury or other causes of abnormal anatomy
- QT greater than 450 ms on EKG
- Allergy to Haldon
- Any altered mental status (GCS <15)
- Pregnancy
- Any abnormalities on neurologic exam
- Any clinician concern that would require CT scan of brain
- Any prisoner or ward of state
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jessica McCoy, Clinical Associate Professor, Western Michigan University School of Medicine |
ClinicalTrials.gov Identifier: | NCT02747511 |
Other Study ID Numbers: |
BMH-2015-0811 |
First Posted: | April 21, 2016 Key Record Dates |
Last Update Posted: | December 12, 2017 |
Last Verified: | December 2017 |
Additional relevant MeSH terms:
Migraine Disorders Headache Pain Neurologic Manifestations Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Haloperidol Haloperidol decanoate Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents |