Migraine HeadacheNCT02492295
Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department
A study testing Propofol in people with Migraine Headache, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 1 Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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"
- Persists with 6/10 or greater pain at one hour after above treatment
- Emergency Department attending feels patient appropriate for propofol treatment
Who cannot join
- 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
Show all 9Show fewer
- Will be driving themselves home from Emergency Department
- Opioid use within the last 6 hours
- Previously enrolled in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
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.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- Propofol
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan, Propoven
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessed by Numeric Pain Score
Numeric pain score 1 hour after completion of propofol administration.
Measured: 60 minutes
Secondary outcomes (11)
Pain Assessed by Numeric Pain Score
Numeric Pain Score
Measured: 24 hours
Pain Assessed by Numeric Pain Score
Numeric pain score 30 minutes after completion of propofol administration.
Measured: 30 minutes
Additional Rescue Medications Used
Need for other pain relief medications for migraine after use of propofol
Measured: 24 hours
Patient Willingness to Use Propofol Again in Case of Refractory Migraine as Assessed by Patient Questionaire
Assessed by questionnaire read to patient over phone (yes/no answer)
Measured: 24 hours
Emergency Room Re-admissions
May reflect treatment failure or occurrence of adverse events/reactions-determined by Response is Yes or No
Measured: 72 hours
Hypoxia: SpO2 of <88%
SpO2 of <88% up to 60 minutes after propofol administration or until patient is fully alert.
Measured: 60 minutes
Hypotension: Blood Pressure of < 100/60
Blood pressure of < 100/60 up to 60 minutes after propofol administration or until patient is fully alert.
Measured: 60 minutes
Number of Patients Needing Basic Airway Repositioning Maneuver During Sedation
Assessed by questionaire filled out by research associate during drug administration. This Will report the number of patients who required a basic airway repositioning maneuver (jaw thrust/head tilt) during the course of the sedation.
Measured: 60 minutes
Number of Patients Needing Advanced Airway Intervention (Beyond Simple Repositioning)(Composite)
Assessed by questionnaire filled out by research associate during drug administration. Will report the composite number of patients (if any) who required an advanced airway maneuver, specifically insertion of a nasal-pharyngeal airway (NPA) or oro-pharyngeal airway (OPA), use of a bag-valve-mask (BVM), endotracheal intubation (ETT) or surgical airway. While only a composite number will be reported as a secondary outcome, we will give details in the text of any such interventions. We *do not* anticipate that any such interventions will be required during the study, and thus are not going to pre-specify the above interventions as separate individual outcome measures, but will instead report a composite number, with relevant details in the text.
Measured: 60 minutes
Number of Patients With Allergic (Anaphylactic-spectrum) Reactions That May be Attributed to Propofol Use (Composite)
Assessed by questionnaire filled out by research associate during and after drug administration. The number of patients (if any) with an anaphylactic-spectrum response will be reported as a composite number, and in the text we will provide a specific description of the reaction(s), which might include itching, urticaria, airway swelling, or wheezing/stridor. Please note that we *do not* anticipate any such reactions to propofol, and thus are not going to pre-specificy these reactions individually as separate outcome measures, but will instead report a composite, with relevant details in the text.
Measured: 60 minutes
Hypercarbia: End Tidal Carbon Dioxide (ETCO2) of >50 mm Hg
ETCO2 of >50 mm Hg up to 60 minutes after propofol administration or until patient is fully alert.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2014
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Why it stopped: Due to logistic reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Gardner, MD, Principal investigator, Albert Einstein Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492295
- Sponsor's protocol ID
- HN4616
- Status last verified
- May 2017
- First submitted
- 25 Mar 2015
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department
- ClinicalTrials.gov ID
- NCT02492295
- Acronym / sponsor ID
- HN4616
- Conditions
- Migraine Headache
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to logistic reason
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: PropofolPropofol 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Diprivan, PropovenPropofol 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. | Drug | Propofol |
Primary outcome
Pain Assessed by Numeric Pain Score
Time frame: 60 minutes
Numeric pain score 1 hour after completion of propofol administration.
11 secondary outcomes
Pain Assessed by Numeric Pain Score
Time frame: 24 hours
Pain Assessed by Numeric Pain Score
Time frame: 30 minutes
Additional Rescue Medications Used
Time frame: 24 hours
Patient Willingness to Use Propofol Again in Case of Refractory Migraine as Assessed by Patient Questionaire
Time frame: 24 hours
Emergency Room Re-admissions
Time frame: 72 hours
Hypoxia: SpO2 of <88%
Time frame: 60 minutes
Hypotension: Blood Pressure of < 100/60
Time frame: 60 minutes
Number of Patients Needing Basic Airway Repositioning Maneuver During Sedation
Time frame: 60 minutes
Number of Patients Needing Advanced Airway Intervention (Beyond Simple Repositioning)(Composite)
Time frame: 60 minutes
Number of Patients With Allergic (Anaphylactic-spectrum) Reactions That May be Attributed to Propofol Use (Composite)
Time frame: 60 minutes
Hypercarbia: End Tidal Carbon Dioxide (ETCO2) of >50 mm Hg
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Gardner, MD principal investigator
Albert Einstein Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Migraine Headache, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessed by Numeric Pain Score (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.