Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Migraine headache is a frequent Emergency Department complaint. While first-line Emergency Department treatment for this condition is well-established, optimal second-line treatment options are not well-defined. First line Emergency Department treatments include Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), dopamine antagonists. Second line treatments that have been proposed include triptans, steroids, antiepileptics, benzodiazepines, magnesium and narcotics, but none have shown reliable Emergency Department efficacy (less than 50% in most studies). In the past ten years there have been several case series published on using low, sub-anesthetic doses of propofol for the treatment of refractory migraine. These case series have reported very impressive efficacy rates, especially in comparison to the published efficacy rates of other second-line treatments. Personal experience using this treatment modality has also yielded impressive clinical results. Most of the published series, however, have not been conducted in the Emergency Department.

The Investigators propose to conduct a prospective, observational trial of low-dose propofol for the treatment of refractory migraine in the Emergency Department. Propofol is a frequently-used Emergency Department sedative, with a good safety profile when administered by experienced Emergency Medicine practitioners using appropriate monitoring. The primary outcome measurement will be reduction of pain after treatment, with secondary outcome measures related to the safety of treatment and continuation of pain relief after leaving the Emergency Department. Although the protocol will involve the use of low-dose propofol with the aim of achieving light-to-moderate sedation only, all patients will care for and monitor at a level appropriate for deep procedural sedation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Age between 18 and 65

• Chief complaint consistent with the diagnosis of headache that meets 2 of the 4 following criteria (check all that apply):

• Unilateral Headache

• Pulsatile Sensation

• Moderate to Severe pain intensity

• Aggravation by physical activity or causing avoidance of physical activity (i.e. climbing stairs, walking)

• Headache is associated with at least one of the following symptoms (check all that apply):

• Nausea and/or vomiting

• Photophobia and/or phonophobia

• History of at least 5 similar headaches

• Within 6 hours of screening has received BOTH (via IV or PO):

1. A Non-Steroidal Anti-Inflammatory Drug (NSAID):

Ibuprofen / "Motrin" Naproxen / "Aleve" Ketorolac / "Toradol"

2. A Dopamine-Antagonist:

Metoclopramide / "Reglan" Prochlorperazine / "Compazine"

• Persists with 6/10 or greater pain at one hour after above treatment

• Emergency Department attending feels patient appropriate for propofol treatment

Exclusion Criteria:

• Allergy to the study medication / eggs / soy (medication components)

• Inability to provide written, informed consent

• Employee or in police custody

• Pregnant or breast-feeding

• Medical concerns: Chronic obstructive pulmonary disease, active asthma exacerbation, obstructive sleep apnea, morbid obesity (Body Mass Index > 40), American Society of Anaesthesiologists class 3 or greater, actively intoxicated, Blood Pressure < 110/70

• Meal or heavy snack within 3 hours of sedation time

• Will be driving themselves home from Emergency Department

• Opioid use within the last 6 hours

• Previously enrolled in this study