This trial is active, not recruiting.

Conditions headache, migraine disorders
Treatments haloperidol, placebo
Phase phase 4
Sponsor Western Michigan University School of Medicine
Start date October 2015
End date October 2016
Trial size 159 participants
Trial identifier NCT02747511, BMH-2015-0811


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
(Placebo Comparator)
placebo 0.9% Sodium Chloride

Primary Outcomes

>50% reduction in pain per Visual Analog Scale (VAS)
time frame: 90 minute interval

Eligibility Criteria

Male or female participants from 13 years up to 55 years old.

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

Additional Information

Official title Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Western Michigan University School of Medicine.