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IV Haloperidol for the Treatment of Headache in the ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02747511
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Jessica McCoy, Western Michigan University School of Medicine

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

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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 :
  1. >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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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:
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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