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IV Haloperidol for the Treatment of Headache in the ED

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ClinicalTrials.gov Identifier: NCT02747511
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Jessica McCoy, Western Michigan University School of Medicine

Tracking Information
First Submitted Date  ICMJE April 19, 2016
First Posted Date  ICMJE April 21, 2016
Last Update Posted Date December 12, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
>50% reduction in pain per Visual Analog Scale (VAS) [ Time Frame: 90 minute interval ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Haloperidol for the Treatment of Headache in the ED
Official Title  ICMJE Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Headache
  • Migraine Disorders
Intervention  ICMJE
  • Drug: Haloperidol
  • Drug: Placebo
    Other Name: 0.9% Sodium Chloride
Study Arms  ICMJE
  • Active Comparator: Haloperidol
    Intervention: Drug: Haloperidol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2017)
118
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2016)
159
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02747511
Other Study ID Numbers  ICMJE BMH-2015-0811
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jessica McCoy, Western Michigan University School of Medicine
Study Sponsor  ICMJE Western Michigan University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Western Michigan University School of Medicine
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP