Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches, Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 7 - 18 |
| Updated: | 1/25/2019 |
| Start Date: | June 2015 |
| End Date: | December 2019 |
| Contact: | Deryk Walsh, MD |
| Email: | deryk.walsh@childrens.com |
| Phone: | 214-456-6393 |
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.
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.
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
We found this trial at
1
site
Dallas, Texas 75235
Principal Investigator: Deryk Walsh, MD
Phone: 214-456-8981
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