Trial Outcomes & Findings for Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients (NCT NCT02485418)

NCT ID: NCT02485418

Last Updated: 2024-03-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Duration of propofol infusion (between 5 and 60 minutes)
• Results posted on: 2024-03-06

Participant Flow

Participants were recruited from two headache clinic populations

Forty patients met criteria and were enrolled.

Participant milestones

Measure	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 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.
Overall Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Propofol Infusion n=38 Participants 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 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.
Age, Continuous	14.7 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants
Number of Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of propofol infusion (between 5 and 60 minutes)

Population: Per protocol, analysis of data based on patients completing 60 minute infusion of propofol

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

Outcome measures

Measure

Propofol Infusion n=40 Participants 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 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.

Improvement in Headache Pain Score

-3.3 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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

For subjects who experience a change in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain.

Outcome measures

Measure	Propofol Infusion n=38 Participants 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 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.
NPRS Pain Scores at 24 and 48 Hours Post Infusion Baseline	7.5 Pain Score 0-10 scale Standard Deviation 1.3
NPRS Pain Scores at 24 and 48 Hours Post Infusion 24 hours post infusion	4.3 Pain Score 0-10 scale Standard Deviation 2.6
NPRS Pain Scores at 24 and 48 Hours Post Infusion 48 hours post infusion	3.4 Pain Score 0-10 scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 60 minutes

Total dose of propofol administered (mg/kg)

Outcome measures

Measure

Propofol Infusion n=38 Participants 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 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.

Total Propofol Dose

2.1 mg/kg Standard Deviation 0

Adverse Events

Propofol Infusion

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure

Propofol Infusion n=38 participants at risk 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 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.

Gastrointestinal disorders emesis, abdominal pain & fever

2.6% 1/38 • Number of events 1 • 48 hours Adverse events were collected by nursing at time of infusion and 24 and 48 hours post infusion by phone communication. All-Cause Mortality was not monitored/assessed.

Other adverse events

Measure

Propofol Infusion n=38 participants at risk 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 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.

Gastrointestinal disorders nausea

5.3% 2/38 • Number of events 2 • 48 hours Adverse events were collected by nursing at time of infusion and 24 and 48 hours post infusion by phone communication. All-Cause Mortality was not monitored/assessed.

Additional Information

Deryk Walsh, MD

University of Texas Southwestern

Phone: 2144566393

Email: deryk.walsh@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place