IV Haloperidol for the Treatment of Headache in the ED

December 8, 2017 updated by: Jessica McCoy, Western Michigan University School of Medicine

Intravenous Haloperidol for the Treatment of Headache in the Emergency Department

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Other Names:
  • 0.9% Sodium Chloride
ACTIVE_COMPARATOR: Haloperidol
Drug: Haloperidol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Michigan University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (ESTIMATE)

April 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMH-2015-0811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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