Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients (Propofol2014)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485418
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Deryk Walsh, University of Texas Southwestern Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Propofol has been used in adult populations to treat migraines as an abortive agent. Investigators plan to investigate its efficacy as an abortive agent in the pediatric population when administered as a safe low-dose infusion. Goals of the study are to:

  1. Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches
  2. Evaluate effective and safe dosing limits in pediatric populations
  3. Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent

Endpoints for the study will be:

  1. Number of enrolled patients
  2. Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under the guidance and supervision of a board certified pediatric anesthesiologist with the appropriate monitoring equipment and readily available emergency equipment. Investigators hope to demonstrate more rapid improvement and decreased side-effect as compared to standard care.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: Propofol Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Study Start Date : June 2015
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Propofol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Propofol infusion

All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:

20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes

 Drug: Propofol
Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Improvement in Headache Pain Score [ Time Frame: Duration of propofol infusion (between 5 and 60 minutes) ]
    Reduction in pain score on 0-10 Numeric Pain Rating Scale. Subjects assessed at 5 minute intervals for the duration of the infusion


Secondary Outcome Measures :
  1. Duration of analgesia [ Time Frame: Assessments at 10 minute intervals from the start of infusion while on site, and at 24 and 48 hours after discharge, up to 72 hours. ]
    For subjects who experience improvement in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores.

  2. Total propofol dose [ Time Frame: 60 minutes ]
    Total dose of propofol administered (mg/kg)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of migraine headache per ICHD - 3 (International Classification of Headache Disorders)
  • The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache
  • Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale
  • Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale
  • Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care
  • Patients age 7-18 years old
  • Gender: both male and female
  • Appropriate fasting interval as per ASA guidelines

Exclusion Criteria:

  • No long acting triptan therapy within 24 hours
  • No shorter acting triptan therapy within 6 hours
  • No ergot alkaloid derivatives within the last 24 hours
  • No opioid within 2 hours
  • No NSAID or acetaminophen within 1 hour of infusion
  • Use of sedative medications within 6 hours of infusion, including opioids, benzodiazepines, barbiturates
  • Headache not consistent with subject's headache history needing further work-up
  • Headache duration less than 24 hours
  • Subjects in which an intravenous line could not be secured
  • Subjects with history of significant reflux or hiatal hernia
  • Subjects with history of significant cardio pulmonary disorders
  • Patient not fasting as per ASA guidelines
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485418


Contacts
Layout table for location contacts
Contact: Deryk Walsh, MD 214-456-6393 deryk.walsh@childrens.com
Contact: Jordan Schutt 214-456-8981 jordan.schutt@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
Children's Health Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Jordan Schutt    214-456-8981    jordan.schutt@utsouthwestern.edu   
Principal Investigator: Deryk Walsh, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Deryk Walsh, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02485418    
Other Study ID Numbers: STU 042014-002
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
 Neurologic Manifestations
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics