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

NCT02485418 | Completed Results

• 1 other identifier: STU 042014-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches
2. 2.Evaluate effective and safe dosing limits in pediatric populations
3. 3.Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent
4. 4.Number of enrolled patients
5. 5.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.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NPRS Pain Scores at 24 and 48 Hours Post Infusion

  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

• Total Propofol Dose

  60 minutes

Study Arms (1)

Propofol infusion

EXPERIMENTAL

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

Drug: Propofol

Interventions

Propofol 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.

Propofol infusion

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Health Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Propofol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Deryk Walsh, MD
• Organization: University of Texas Southwestern

deryk.walsh@utsouthwestern.edu

2144566393

Study Officials

• Deryk Walsh, MD

  Children's Medical Center Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 30, 2015
• Study Start: June 1, 2015
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02

Locations

US (1)