IV Haloperidol for the Treatment of Headache in the ED

W

Western Michigan University School of Medicine

Status and phase

Completed
Phase 4

Conditions

Migraine Disorders
Headache

Treatments

Drug: Haloperidol
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02747511
BMH-2015-0811

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

All

Ages

13 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

118 participants in 2 patient groups, including a placebo group

Haloperidol
Active Comparator group
Treatment:
Drug: Haloperidol
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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