Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT02485418|
Recruitment Status : Unknown
Verified October 2016 by Deryk Walsh, University of Texas Southwestern Medical Center.
Recruitment status was: Recruiting
First Posted : June 30, 2015
Last Update Posted : October 27, 2016
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:
- Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches
- Evaluate effective and safe dosing limits in pediatric populations
- Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent
Endpoints for the study will be:
- Number of enrolled patients
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||October 2017|
Experimental: Propofol infusion
All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:
20 mcg/kg/min for 20 minutes, followed by an increase to 30 mcg/kg/min for 20 minutes and then by an increase to 40 mcg/kg/min for 20 minutes
Intravenous propofol infusion at 20 mcg/kg/min for 20 minutes, followed by an increase to 30 mcg/kg/min for 20 minutes and then by an increase to 40 mcg/kg/min for 20 minutes.
- 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
- 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.
- Total propofol dose [ Time Frame: 60 minutes ]Total dose of propofol administered (mg/kg)
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
|United States, Texas|
|Children's Health Children's Medical Center Dallas||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Roxana Ploski 214-456-8559 email@example.com|
|Principal Investigator: Deryk Walsh, MD|