Trial Outcomes & Findings for Low-dose Propofol for Pediatric Migraine (NCT NCT01604785)

NCT ID: NCT01604785

Last Updated: 2018-12-31

Results Overview

Percent pain change after initial treatment using 10 point VAS scale

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 74 participants
• Primary outcome timeframe: 15 minutes after administration
• Results posted on: 2018-12-31

Participant Flow

Participant milestones

Measure	Experimental Treatment Group Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses Total enrollment = 37 subjects	Standard Treatment Group Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide Total enrollment = 37 subjects
Overall Study STARTED	37	37
Overall Study COMPLETED	30	36
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Measure	Experimental Treatment Group Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses Total enrollment = 37 subjects	Standard Treatment Group Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide Total enrollment = 37 subjects
Overall Study Repeat Visits Not Included in Analysis	7	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Experimental Treatment Group n=30 Participants Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses	Standard Treatment Group n=36 Participants Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide	Total n=66 Participants Total of all reporting groups
Age, Continuous	14.6 years STANDARD_DEVIATION 2.1 • n=30 Participants	14.6 years STANDARD_DEVIATION 3.0 • n=36 Participants	14.6 years STANDARD_DEVIATION 2.8 • n=66 Participants
Sex: Female, Male Female	21 Participants n=30 Participants	28 Participants n=36 Participants	49 Participants n=66 Participants
Sex: Female, Male Male	9 Participants n=30 Participants	8 Participants n=36 Participants	17 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 Participants n=30 Participants	36 Participants n=36 Participants	66 Participants n=66 Participants

PRIMARY outcome

Timeframe: 15 minutes after administration

Percent pain change after initial treatment using 10 point VAS scale

Outcome measures

Measure	Experimental Treatment Group n=30 Participants Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses Total enrollment = 30 subjects	Standard Treatment Group n=36 Participants Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide Total enrollment = 36 subjects
Change in Self-Assessed Pain	51 percentage change	59 percentage change

SECONDARY outcome

Timeframe: 24 hours

Population: Percentage of participants

Percentage of subjects reporting recurrence of headache with pain greater than at time of discharge from Emergency Department

Outcome measures

Measure	Experimental Treatment Group n=30 Participants Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses Total enrollment = 30 subjects	Standard Treatment Group n=36 Participants Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide Total enrollment = 36 subjects
Rebound Headache at 24 Hour Follow-up Phone Call	25 Percentage of subjects reporting rebound	66.7 Percentage of subjects reporting rebound

SECONDARY outcome

Timeframe: Duration of stay in Emergency Department in Minutes

Length of stay from administration of medication to Emergency Department discharge in minutes

Outcome measures

Measure	Experimental Treatment Group n=30 Participants Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses Total enrollment = 30 subjects	Standard Treatment Group n=36 Participants Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide Total enrollment = 36 subjects
Emergency Department Length of Stay	79 Minutes Interval 22.0 to 460.0	111 Minutes Interval 42.0 to 630.0

Adverse Events

Experimental Treatment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Treatment Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Experimental Treatment Group n=30 participants at risk Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses	Standard Treatment Group n=36 participants at risk Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide
Nervous system disorders Extrapyramidal Symptoms	0.00% 0/30	8.3% 3/36 • Number of events 3
Respiratory, thoracic and mediastinal disorders Hypoxemia	3.3% 1/30 • Number of events 1	0.00% 0/36

Additional Information

David Sheridan

Oregon Health & Science University

Phone: 503 494-8311

Email: sheridda@ohsu.edu

Results disclosure agreements

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