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IV Haloperidol for the Treatment of Headache in the ED

Primary Purpose

Headache, Migraine Disorders

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Haloperidol
Placebo
Sponsored by
Western Michigan University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

13 Years - 55 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Haloperidol

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    >50% reduction in pain per Visual Analog Scale (VAS)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2016
    Last Updated
    December 8, 2017
    Sponsor
    Western Michigan University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02747511
    Brief Title
    IV Haloperidol for the Treatment of Headache in the ED
    Official Title
    Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    October 2017 (Actual)
    Study Completion Date
    October 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western Michigan University School of Medicine

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Headache, Migraine Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Haloperidol
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Haloperidol
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    0.9% Sodium Chloride
    Primary Outcome Measure Information:
    Title
    >50% reduction in pain per Visual Analog Scale (VAS)
    Time Frame
    90 minute interval

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32402480
    Citation
    McCoy JJ, Aldy K, Arnall E, Petersen J. Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial. J Emerg Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.jemermed.2020.04.018. Epub 2020 May 10.
    Results Reference
    derived

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    IV Haloperidol for the Treatment of Headache in the ED

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