Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

There has been little advancement in abortive migraine therapies in recent decades, and few proven treatments exist for acute migraine, particularly in children. 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.

All subjects presenting to the pediatric emergency department with signs/symptoms of migraine headache will be screened for the study. Subjects who are eligible will be provided information about the study and consent/assent forms from a member of the research team, and asked whether they are interested in participating.

All study subjects will receive acetaminophen (Tylenol) or ibuprofen (Motrin) for their headache if they have not already tried these first-line treatments at home; those with persistent symptoms requiring further treatment who consent to participate in the study will be randomized to receive either standard treatment or propofol. 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. During treatment they will have close monitoring of their vital signs. No additional laboratory tests or procedures are involved. 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.

The study data will be presented in summary tables that outline subjects' clinical presentation prior to treatments, and response to study drug during their visit. The main variables of interest include effectiveness (determined as a reduction in self-reported pain score), length of stay in the pediatric emergency department, recurrent headache requiring emergency treatment within 24 hours and whether any adverse effects occur. These will be compared between the 2 study groups with basic statistics. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01604785
Study type Interventional
Source Oregon Health and Science University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 2012
Completion date August 2016

See also
  Status Clinical Trial Phase
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Not yet recruiting NCT05943457 - Vitamin K2 Supplementation in Adult Episodic Migraine N/A
Completed NCT01211145 - Zomig - Treatment of Acute Migraine Headache in Adolescents Phase 4
Completed NCT00530517 - A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack Phase 2
Completed NCT00898677 - Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) Phase 3
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT03971071 - A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache Phase 4
Withdrawn NCT02706015 - Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks Phase 3
Terminated NCT02375789 - Intranasal Cooling for Symptomatic Relief of Migraine N/A
Completed NCT02518464 - Ticagrelor Therapy for RefrACTORy Migraine Study Phase 4
Terminated NCT00391755 - A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches Phase 4
Completed NCT03401346 - Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults Phase 1
Completed NCT05085483 - Ketone for Migraine Prevention N/A
Terminated NCT00804973 - Study in Participants With Acute Migraines Headaches Phase 2
Completed NCT03341689 - Psilocybin for the Treatment of Migraine Headache Phase 1
Completed NCT01630044 - Neurostimulation Device for Treatment of Migraine Headache N/A
Active, not recruiting NCT00285402 - Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine Phase 2
Completed NCT00203255 - Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache N/A
Recruiting NCT06046508 - Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)
Active, not recruiting NCT04584762 - Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine N/A