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

NCT ID: NCT02485418

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2023-01-24

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.

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.

Conditions

Migraine Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Deryk Walsh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deryk Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Medical Center Dallas

Locations

Children's Health Children's Medical Center Dallas

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STU 042014-002

Identifier Type: -

Identifier Source: org_study_id