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IV Haloperidol for the Treatment of Headache in the ED

NCT ID: NCT02747511

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Headache Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Haloperidol

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Haloperidol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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0.9% Sodium Chloride

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Michigan University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jessica McCoy

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 32402480 (View on PubMed)

Other Identifiers

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BMH-2015-0811

Identifier Type: -

Identifier Source: org_study_id