Migraine HeadachePropofol2014NCT02485418
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
A study testing Propofol in people with Migraine Headache, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Propofol has been used in adult populations to treat migraines as an abortive agent. Investigators plan to investigate its efficacy as an abortive agent in the pediatric population when administered as a safe low-dose infusion. Goals of the study are to: 1. Read more about this study
- Who is it for?
- Ages 7 to 18 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 24 Jan 2023
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a diagnosis of migraine headache per ICHD - 3 (International Classification of Headache Disorders)
- The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache
- Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale
- Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale
- Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care
- Patients age 7-18 years old
- Gender: both male and female
- Appropriate fasting interval as per ASA guidelines
Who cannot join
- No long acting triptan therapy within 24 hours
- No shorter acting triptan therapy within 6 hours
- No ergot alkaloid derivatives within the last 24 hours
- No opioid within 2 hours
- No NSAID or acetaminophen within 1 hour of infusion
- Use of sedative medications within 6 hours of infusion, including opioids, benzodiazepines, barbiturates
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- Headache not consistent with subject's headache history needing further work-up
- Headache duration less than 24 hours
- Subjects in which an intravenous line could not be secured
- Subjects with history of significant reflux or hiatal hernia
- Subjects with history of significant cardio pulmonary disorders
- Patient not fasting as per ASA guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health Children's Medical Center Dallas
Dallas, Texas, 75235
About this study
Propofol has been used in adult populations to treat migraines as an abortive agent. Investigators plan to investigate its efficacy as an abortive agent in the pediatric population when administered as a safe low-dose infusion. Goals of the study are to:
- Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches
- Evaluate effective and safe dosing limits in pediatric populations
- Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent
Read more
Endpoints for the study will be:
- Number of enrolled patients
- Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under the guidance and supervision of a board certified pediatric anesthesiologist with the appropriate monitoring equipment and readily available emergency equipment. Investigators hope to demonstrate more rapid improvement and decreased side-effect as compared to standard care.
Read the detailed description
The aim of this prospective study is to evaluate the efficacy and safety of propofol administration in a hospital setting, as an abortive medication for children aged 7-18 with migraines.
Primary outcome:
Based on the adult and the limited pediatric data available we hypothesize that propofol infusion in sub anesthetic dose, will result in either complete resolution or improve the headache pain scores by 50% from the baseline pain scores. Patients will be assessed with a 0-10 Numeric Pain Rating Scale.
Secondary outcomes:
- Time to beginning of effect (from the beginning of the propofol infusion till first improvement in pain score noted)
- Duration of effect (from the end of propofol administration till discharge criteria are meet or if treatment is ineffective, till start of new therapy)
- Total propofol dose based on weight.
Prior to initiation of DHE infusion, the subjects will receive sub-anesthetic doses of propofol infusion:
20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes. The propofol infusion will be terminated if:
- The patient has no pain, or greater than 50% reduction in pain scores as compared to the pretreatment pain score
- After completing 40 minutes of propofol infusion at 40 mcg/kg/min irrespective of the pain score
- If the anesthesiologist feels cardio-pulmonary depression, airway obstruction or over sedation (Ramsay Sedation Score greater than 3)has occurred
If the propofol infusion is effective in resolving headache symptoms, then subjects will be monitored for at least 30 minutes after termination of infusion. Outpatient subjects would then be discharged home; inpatient subjects would resume standard care treatment.
If propofol infusion is not successful in resolving headache, then the subjects will proceed with DHE infusion per standard of care. If the subject still has no relief, the study investigators will discuss further options with the subject and parents, including hospital admission for further therapy for outpatient subjects.
For all subjects who receive propofol infusion, follow-up will occur at 24 and 48 hours via phone call to evaluate headache status and recover information on headache symptoms and side effects.
- 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
Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Propofol infusion | Experimental | All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:
20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Headache Pain Score
Change in pain score on 0-10 Numeric Pain Rating Scale with 0 being no pain and 10 being severe pain. Subjects assessed at 10 minute intervals for the duration of the infusion with reporting of change from baseline to 60 minutes
Measured: Duration of propofol infusion (between 5 and 60 minutes)
Secondary outcomes (2)
NPRS Pain Scores at 24 and 48 Hours Post Infusion
For subjects who experience a change in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain.
Measured: Assessments of NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain at 24 and 48 hours after discharge from infusion
Total Propofol Dose
Total dose of propofol administered (mg/kg)
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 posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
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.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deryk Walsh, University of Texas Southwestern Medical Center
- Investigators
- Deryk Walsh, MD, Principal investigator, Children's Medical Center Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485418
- Sponsor's protocol ID
- STU 042014-002
- Acronym
- Propofol2014
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2015
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02485418
- Acronym / sponsor ID
- Propofol2014 / STU 042014-002
- Conditions
- Migraine Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Propofol has been used in adult populations to treat migraines as an abortive agent. Investigators plan to investigate its efficacy as an abortive agent in the pediatric population when administered as a safe low-dose infusion. Goals of the study are to:
- Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches
- Evaluate effective and safe dosing limits in pediatric populations
- Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent
Endpoints for the study will be:
- Number of enrolled patients
- Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under the guidance and supervision of a board certified pediatric anesthesiologist with the appropriate monitoring equipment and readily available emergency equipment. Investigators hope to demonstrate more rapid improvement and decreased side-effect as compared to standard care.
Detailed description
The aim of this prospective study is to evaluate the efficacy and safety of propofol administration in a hospital setting, as an abortive medication for children aged 7-18 with migraines.
Primary outcome:
Based on the adult and the limited pediatric data available we hypothesize that propofol infusion in sub anesthetic dose, will result in either complete resolution or improve the headache pain scores by 50% from the baseline pain scores. Patients will be assessed with a 0-10 Numeric Pain Rating Scale.
Secondary outcomes:
- Time to beginning of effect (from the beginning of the propofol infusion till first improvement in pain score noted)
- Duration of effect (from the end of propofol administration till discharge criteria are meet or if treatment is ineffective, till start of new therapy)
- Total propofol dose based on weight.
Prior to initiation of DHE infusion, the subjects will receive sub-anesthetic doses of propofol infusion:
20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes. The propofol infusion will be terminated if:
- The patient has no pain, or greater than 50% reduction in pain scores as compared to the pretreatment pain score
- After completing 40 minutes of propofol infusion at 40 mcg/kg/min irrespective of the pain score
- If the anesthesiologist feels cardio-pulmonary depression, airway obstruction or over sedation (Ramsay Sedation Score greater than 3)has occurred
If the propofol infusion is effective in resolving headache symptoms, then subjects will be monitored for at least 30 minutes after termination of infusion. Outpatient subjects would then be discharged home; inpatient subjects would resume standard care treatment.
If propofol infusion is not successful in resolving headache, then the subjects will proceed with DHE infusion per standard of care. If the subject still has no relief, the study investigators will discuss further options with the subject and parents, including hospital admission for further therapy for outpatient subjects.
For all subjects who receive propofol infusion, follow-up will occur at 24 and 48 hours via phone call to evaluate headache status and recover information on headache symptoms and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol infusion | Experimental | Drug: PropofolAll subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule: 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients with a diagnosis of migraine headache per ICHD - 3 (International Classification of Headache Disorders)
- The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache
- Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale
- Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale
- Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care
Key exclusion criteria (12 listed)
- No long acting triptan therapy within 24 hours
- No shorter acting triptan therapy within 6 hours
- No ergot alkaloid derivatives within the last 24 hours
- No opioid within 2 hours
- No NSAID or acetaminophen within 1 hour of infusion
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 |
|---|---|---|
| PropofolIntravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes. | Drug | Propofol infusion |
Primary outcome
Improvement in Headache Pain Score
Time frame: Duration of propofol infusion (between 5 and 60 minutes)
Change in pain score on 0-10 Numeric Pain Rating Scale with 0 being no pain and 10 being severe pain. Subjects assessed at 10 minute intervals for the duration of the infusion with reporting of change from baseline to 60 minutes
2 secondary outcomes
NPRS Pain Scores at 24 and 48 Hours Post Infusion
Time frame: Assessments of NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain at 24 and 48 hours after discharge from infusion
Total Propofol Dose
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 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deryk Walsh, MD principal investigator
Children's Medical Center Dallas
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 University of Texas Southwestern Medical Center 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 6 Mar 2024. 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 6 Mar 2024). 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?
Improvement in Headache Pain Score (time frame: Duration of propofol infusion (between 5 and 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 6 Mar 2024.