Migraine Headache Clinical Trial
— Propofol2014Official title:
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Verified date | February 2024 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 24, 2023 |
Est. primary completion date | January 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Health Children's Medical Center Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Headache Pain Score | Change in pain score on 0-10 Numeric Pain Rating Scale with 0 being no pain and 10 being severe pain. Subjects assessed at 10 minute intervals for the duration of the infusion with reporting of change from baseline to 60 minutes | Duration of propofol infusion (between 5 and 60 minutes) | |
Secondary | NPRS Pain Scores at 24 and 48 Hours Post Infusion | For subjects who experience a change in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain. | Assessments of NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain at 24 and 48 hours after discharge from infusion | |
Secondary | Total Propofol Dose | Total dose of propofol administered (mg/kg) | 60 minutes |
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