Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department
Information source: Albert Einstein Healthcare Network
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache
Intervention: Propofol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Albert Einstein Healthcare Network Official(s) and/or principal investigator(s): James Gardner, MD, Principal Investigator, Affiliation: Albert Einstein Health Network
Overall contact: Rashmi Manur, MD, Phone: 215-456-3935, Email: ManurRas@einstein.edu
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.
Clinical Details
Official title: Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pain assessed by Numeric pain score
Secondary outcome: Pain assessed by Numeric pain scorePain assessed by Numeric pain score Additional rescue medications used Patient willingness to use propofol again in case of refractory migraine as assessed by patient questionaire Emergency room re-admissions Hypoxia: SpO2 of <88% Hypotension: Blood pressure of < 100/60 Number of patients needing basic airway repositioning maneuver during sedation Number of patients needing advanced airway intervention (beyond simple repositioning)(composite) Number of patients with allergic (anaphylactic-spectrum) reactions that may be attributed to propofol use (composite) Hypercarbia: End Tidal Carbon Dioxide (ETCO2) of >50 mm Hg
Detailed description:
This is a prospective, open-label, observational trial to assess basic efficacy and safety
in the Emergency Department treatment environment.
Emergency Department patients at Einstein Medical Center Philadelphia, with migraine type
headache (International Headache Classification), who continue to have severe (6/10 or
greater) pain one hour after receiving adequate first-line treatment with a dopamine
antagonist (prochlorperazine or metoclopramide) and an NSAID (ketorolac or ibuprofen) will
be approached for possible inclusion. Patients who meet all inclusion/exclusion criteria
will be given informed consent, including consent for procedural sedation. Patients who
decline to participate will continue to have their headache treated by the ED team as per
usual practice.
After enrollment, patients will be set up for procedural sedation per standard Emergency
Department protocol. This includes a well-running peripheral IV; continuous monitoring with
telemetry, pulse oximetry, capnography and automated blood pressure checks; continuous
bedside monitoring by both an Emergency Department nurse and an Emergency Department
attending or senior resident (with immediate attending availability); and airway management
tools including suction, oxygen, and Bag valve mask ventilation at bedside, with advanced
airway management tools (intubation equipment, etc) immediately available. After time-out,
propofol administration will begin. The study drug will be administered only by those
properly trained to do so and will be administered in compliance with healthcare licensure
requirements. 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 Richmond Agitation Sedation
Scale (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.
If a patient experiences any adverse safety event that in the determination of the treating
provider make it unsafe to continue giving propofol, the protocol will be terminated
immediately.
Numeric pain score (0-10) will be obtained prior to medication administration, at 30 minutes
and at 60 minutes after the final dose of medication. Patients will also be questioned
about associated migraine symptoms (nausea/vomiting/photophobia/phonophobia) and their
resolution. Patients will receive follow-up phone calls at 24 hours to assess pain score,
need for additional medications and whether they would opt for the same treatment again in
the event of another severe headache. Patient charts will subsequently be reviewed to
determine if they had any further ED visits within 72 hours after propofol administration.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Rashmi Manur, MD, Phone: 215-456-3935, Email: ManurRas@einstein.edu
Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States; Recruiting Rashmi Manur, MD, Phone: 215-456-3935, Email: manurras@einstein.edu James Gardner, MD, Principal Investigator Kristen Rizzo, MD, Sub-Investigator Kenneth Deitch, DO, Sub-Investigator
Additional Information
Starting date: August 2014
Last updated: July 6, 2015
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