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IV Haloperidol for the Treatment of Headache in the ED

Intravenous Haloperidol for the Treatment of Headache in the Emergency Department

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02747511
Enrollment
118
Registered
2016-04-21
Start date
2015-10-31
Completion date
2017-10-31
Last updated
2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine Disorders

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.

Interventions

DRUGHaloperidol
DRUGPlacebo

Sponsors

Western Michigan University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
13 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026