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Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients (Propofol2014)

Primary Purpose

Migraine Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propofol
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Health Children's Medical Center Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Propofol infusion

Arm Description

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

Outcomes

Primary Outcome Measures

Improvement in Headache Pain Score
Reduction in pain score on 0-10 Numeric Pain Rating Scale. Subjects assessed at 5 minute intervals for the duration of the infusion

Secondary Outcome Measures

Duration of analgesia
For subjects who experience improvement in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores.
Total propofol dose
Total dose of propofol administered (mg/kg)

Full Information

First Posted
June 4, 2015
Last Updated
August 29, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02485418
Brief Title
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Acronym
Propofol2014
Official Title
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
January 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches Evaluate effective and safe dosing limits in pediatric populations Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent Endpoints for the study will be: Number of enrolled patients 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol infusion
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in Headache Pain Score
Description
Reduction in pain score on 0-10 Numeric Pain Rating Scale. Subjects assessed at 5 minute intervals for the duration of the infusion
Time Frame
Duration of propofol infusion (between 5 and 60 minutes)
Secondary Outcome Measure Information:
Title
Duration of analgesia
Description
For subjects who experience improvement in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores.
Time Frame
Assessments at 10 minute intervals from the start of infusion while on site, and at 24 and 48 hours after discharge, up to 72 hours.
Title
Total propofol dose
Description
Total dose of propofol administered (mg/kg)
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Children's Health Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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

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