Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches, Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | February 2016 |
| Contact: | Rashmi Manur, MD |
| Email: | ManurRas@einstein.edu |
| Phone: | 215-456-3935 |
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.
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.
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.
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.
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
We found this trial at
1
site
5501 Old York Road
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
215-456-7890
Principal Investigator: James Gardner, MD
Phone: 215-456-3935
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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