Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT02485418
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2015-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Propofol2014
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.
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.
Detailed Description:
The aim of this prospective study is to evaluate the efficacy and safety of propofol administration in a hospital setting, as an abortive medication for children aged 7-18 with migraines.
Primary outcome:
Based on the adult and the limited pediatric data available we hypothesize that propofol infusion in sub anesthetic dose, will result in either complete resolution or improve the headache pain scores by 50% from the baseline pain scores. Patients will be assessed with a 0-10 Numeric Pain Rating Scale.
Secondary outcomes:
* Time to beginning of effect (from the beginning of the propofol infusion till first improvement in pain score noted)
* Duration of effect (from the end of propofol administration till discharge criteria are meet or if treatment is ineffective, till start of new therapy)
* Total propofol dose based on weight.
Prior to initiation of DHE infusion, the subjects will receive sub-anesthetic doses of propofol infusion:
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. The propofol infusion will be terminated if:
* The patient has no pain, or greater than 50% reduction in pain scores as compared to the pretreatment pain score
* After completing 40 minutes of propofol infusion at 40 mcg/kg/min irrespective of the pain score
* If the anesthesiologist feels cardio-pulmonary depression, airway obstruction or over sedation (Ramsay Sedation Score greater than 3)has occurred
If the propofol infusion is effective in resolving headache symptoms, then subjects will be monitored for at least 30 minutes after termination of infusion. Outpatient subjects would then be discharged home; inpatient subjects would resume standard care treatment.
If propofol infusion is not successful in resolving headache, then the subjects will proceed with DHE infusion per standard of care. If the subject still has no relief, the study investigators will discuss further options with the subject and parents, including hospital admission for further therapy for outpatient subjects.
For all subjects who receive propofol infusion, follow-up will occur at 24 and 48 hours via phone call to evaluate headache status and recover information on headache symptoms and side effects.
Primary outcome:
Based on the adult and the limited pediatric data available we hypothesize that propofol infusion in sub anesthetic dose, will result in either complete resolution or improve the headache pain scores by 50% from the baseline pain scores. Patients will be assessed with a 0-10 Numeric Pain Rating Scale.
Secondary outcomes:
* Time to beginning of effect (from the beginning of the propofol infusion till first improvement in pain score noted)
* Duration of effect (from the end of propofol administration till discharge criteria are meet or if treatment is ineffective, till start of new therapy)
* Total propofol dose based on weight.
Prior to initiation of DHE infusion, the subjects will receive sub-anesthetic doses of propofol infusion:
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. The propofol infusion will be terminated if:
* The patient has no pain, or greater than 50% reduction in pain scores as compared to the pretreatment pain score
* After completing 40 minutes of propofol infusion at 40 mcg/kg/min irrespective of the pain score
* If the anesthesiologist feels cardio-pulmonary depression, airway obstruction or over sedation (Ramsay Sedation Score greater than 3)has occurred
If the propofol infusion is effective in resolving headache symptoms, then subjects will be monitored for at least 30 minutes after termination of infusion. Outpatient subjects would then be discharged home; inpatient subjects would resume standard care treatment.
If propofol infusion is not successful in resolving headache, then the subjects will proceed with DHE infusion per standard of care. If the subject still has no relief, the study investigators will discuss further options with the subject and parents, including hospital admission for further therapy for outpatient subjects.
For all subjects who receive propofol infusion, follow-up will occur at 24 and 48 hours via phone call to evaluate headache status and recover information on headache symptoms and side effects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: