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

NCT02492295 | Terminated Results DMC

• 1 other identifier: HN4616
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

• Pain Assessed by Numeric Pain Score

  Numeric pain score 1 hour after completion of propofol administration.

  60 minutes

Secondary Outcomes (11)

• Pain Assessed by Numeric Pain Score

  24 hours

• Pain Assessed by Numeric Pain Score

  30 minutes

• Additional Rescue Medications Used

  24 hours

• Patient Willingness to Use Propofol Again in Case of Refractory Migraine as Assessed by Patient Questionaire

  24 hours

• Emergency Room Re-admissions

  72 hours

Study Arms (1)

Propofol

EXPERIMENTAL

Propofol is administered intravenously as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 ("light sedation - awakens to voice \<10 seconds") to RASS target of -3 ("moderate sedation - movement or eye opening without eye contact") for 15 minutes.

Drug: Propofol

Interventions

Propofol DRUG

Propofol will be administered as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 ("light sedation - awakens to voice \<10 seconds") to RASS target of -3 ("moderate sedation - movement or eye opening without eye contact") for 15 minutes. No more than 1.5mg/kg of propofol will be administered over this time period. After the sedation session is complete, patients will be allowed to wake up and will be monitored in the ED for at least another hour prior to discharge.

Also known as: Diprivan, Propoven

Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• A Non-Steroidal Anti-Inflammatory Drug (NSAID):
• Ibuprofen / "Motrin" Naproxen / "Aleve" Ketorolac / "Toradol"
• A Dopamine-Antagonist:
• Metoclopramide / "Reglan" Prochlorperazine / "Compazine"

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Propofol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Results Point of Contact

• Title: Kamran Mohiuddin, Director Clinical Research Emergency Department
• Organization: Albert Einstein Medical Center

MOHIUDDK@EISNTEIN.EDU

215-456-2313

Study Officials

• James Gardner, MD

  Albert Einstein Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2017-05

Locations

US (1)