IV Haloperidol for the Treatment of Headache in the ED
Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
1 other identifier
interventional
118
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedDecember 12, 2017
December 1, 2017
2 years
April 19, 2016
December 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
>50% reduction in pain per Visual Analog Scale (VAS)
90 minute interval
Study Arms (2)
Haloperidol
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Emergency Department patients that complain of headache or migraine
- Males and females age 13-55
- English is primary language
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32402480DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
April 19, 2016
First Posted
April 21, 2016
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
December 12, 2017
Record last verified: 2017-12