IV Haloperidol for the Treatment of Headache in the ED | NCT02747511

Studies
IV Haloperidol for the Treatment of Headache in the ED

NCT02747511

Sponsor

Western Michigan University School of Medicine

Status

Completed

Last Update Posted

Dec 12, 2017Actual

Enrollment

118Actual

Phase

Phase 4

Conditions

Headache
Migraine Disorders

Interventions

Haloperidol
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Apr 19, 2016

First Posted Date

Apr 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2017

Last Update Posted Date

Dec 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jessica McCoy, Clinical Associate Professor, Western Michigan University School of MedicinePrincipal Investigator

Lead Sponsor

Western Michigan University School of MedicineOTHER

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Label	Type	Description	Intervention Names
Haloperidol	Active Comparator		Drug: Haloperidol
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Haloperidol	Drug		Haloperidol
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32402480	Derived	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.

Type	Date	Date Unknown
Release	Apr 14, 2020
Reset	Apr 27, 2020
Release	May 31, 2023
Reset	Jun 20, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 14, 2020			Apr 27, 2020
May 31, 2023

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D006220	Haloperidol
D012965	Sodium Chloride

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals
D002712	Chlorides

ID	Term
D006261	Headache
D008881	Migraine Disorders