Trial Outcomes & Findings for Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department (NCT NCT02492295)
NCT ID: NCT02492295
Last Updated: 2020-03-19
Results Overview
Numeric pain score 1 hour after completion of propofol administration.
TERMINATED
NA
12 participants
60 minutes
2020-03-19
Participant Flow
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Participant milestones
| Measure |
Propofol
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.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 60 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Numeric pain score 1 hour after completion of propofol administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Numeric Pain Score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Numeric pain score 30 minutes after completion of propofol administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Need for other pain relief medications for migraine after use of propofol
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Assessed by questionnaire read to patient over phone (yes/no answer)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
May reflect treatment failure or occurrence of adverse events/reactions-determined by Response is Yes or No
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
SpO2 of \<88% up to 60 minutes after propofol administration or until patient is fully alert.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Blood pressure of \< 100/60 up to 60 minutes after propofol administration or until patient is fully alert.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutesPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
ETCO2 of \>50 mm Hg up to 60 minutes after propofol administration or until patient is fully alert.
Outcome measures
Outcome data not reported
Adverse Events
Propofol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kamran Mohiuddin, Director Clinical Research Emergency Department
Albert Einstein Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place