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OpenTrials
Completed

NCT Number: NCT02747511

IV Haloperidol for the Treatment of Headache in the ED

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.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol

Drug

Placebo

Drug

Other names: 0.9% Sodium Chloride

Primary outcomes

  1. >50% reduction in pain per Visual Analog Scale (VAS)

    Time frame: 90 minute interval

Sponsors and collaborators

Lead sponsor

Western Michigan University School of Medicine

Other

Registry information

Official study title

Intravenous Haloperidol for the Treatment of Headache in the Emergency Department

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2016
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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