Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02747511
Other study ID # BMH-2015-0811
Secondary ID
Status Completed
Phase Phase 4
First received April 19, 2016
Last updated December 8, 2017
Start date October 2015
Est. completion date October 2017

Study information

Verified date December 2017
Source Western Michigan University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 13 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Haloperidol

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Western Michigan University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary >50% reduction in pain per Visual Analog Scale (VAS) 90 minute interval
See also
  Status Clinical Trial Phase
Terminated NCT03472872 - A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache Phase 4
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Withdrawn NCT02866084 - Neuromodulation Treatment of Vestibular Migraines N/A
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Not yet recruiting NCT04352218 - Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache Phase 2
Completed NCT02734992 - Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers N/A
Completed NCT01153789 - Study of Oculomotor Dysfunction Leading to Children Vertigo N/A
Completed NCT01327118 - Prostaglandin F2alpha in a Human Headache Model N/A
Not yet recruiting NCT00969995 - Identification of Inflammatory Markers in Migraine Patients N/A
Not yet recruiting NCT00752921 - Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache Phase 4
Terminated NCT00291395 - PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers Phase 1
Completed NCT00212810 - Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache. Phase 4
Completed NCT00263094 - An End to the Yom Kippur (and Ramadan) Headache N/A
Completed NCT00135122 - Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache Phase 3
Completed NCT02475005 - An Intervention to Improve Adolescent Headache Self-management N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Completed NCT01664585 - Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life N/A
Completed NCT04632420 - Evaluation of Headache and Childbirth in a Chronic Pain Population
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease