CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 74 enrolled
Drug / intervention
Propofol +1 moredrug
Likely dose
Propofol 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01604785
NCT01604785Phase 3Completed

Low-dose Propofol for Abortive Therapy of Pediatric Migraine in the Emergency Department

Oregon Health and Science University·interventional·Posted May 24, 2012·Updated Dec 31, 2018

In Brief

A Phase 3 clinical trial evaluating Propofol and Standard Treatment for Migraine Headache. Completed, enrolled 74 participants across 1 site.

Detailed Summary

Propofol, a general anesthetic, has been suggested to be effective for the treatment of migraine headaches in adults when used in subanesthetic doses (lower doses than those used for anesthesia or sedation). Initial retrospective review of the investigators experience with propofol for migraine in children suggests that it is safe and may be more effective than standard treatments used in the emergency department. The investigators retrospective series had a small subject population and a larger study is needed to compare propofol to current available treatments. Standard treatment currently consists of a "cocktail" of medications that include anti-nausea medicines (metoclopramide and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects assigned to the experimental group (Propofol) will receive the same intravenous fluids and up to five doses of propofol. All subjects will undergo assessment of their pain (self-rated on a scale from 0-10) before and after treatment. Post-visit clinical data will be collected from the subject's medical record and subjects will be called by telephone 24-48 hours after discharge from the emergency department to ask how they are doing and whether they required any additional treatments such as home medications or by other medical professionals other than OHSU.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2012
Enrollment StartNov 1, 2012
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.1 years ago

Interventions

Propofoldrug

Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses

Standard Treatmentdrug

Ketorolac, Diphenhydramine and Metoclopramide