IV Haloperidol for the Treatment of Headache in the ED

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