IV Haloperidol for the Treatment of Headache in the ED

Overview

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.

Full Title of Study: “Intravenous Haloperidol for the Treatment of Headache in the Emergency Department”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2017

Interventions

  • Drug: Haloperidol
  • Drug: Placebo

Arms, Groups and Cohorts

  • Active Comparator: Haloperidol
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • >50% reduction in pain per Visual Analog Scale (VAS)
    • Time Frame: 90 minute interval

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Western Michigan University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jessica McCoy, Clinical Associate Professor – Western Michigan University School of Medicine

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