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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:
Endpoints for the study will be:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Duration of propofol infusion (between 5 and 60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deryk Walsh, MD | Children's Medical Center Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Health Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
Forty patients met criteria and were enrolled.
Participants were recruited from two headache clinic populations
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol Infusion | 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 Propofol: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
40 patients screened and 2 patients excluded and baseline characteristics not included
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol Infusion | 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 Propofol: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Per protocol, analysis of data based on patients completing 60 minute infusion of propofol | Posted | Mean | Standard Deviation | score on a scale | Duration of propofol infusion (between 5 and 60 minutes) |
|
48 hours
Adverse events were collected by nursing at time of infusion and 24 and 48 hours post infusion by phone communication.
All-Cause Mortality was not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol Infusion | 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 Propofol: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| emesis, abdominal pain & fever | Gastrointestinal disorders | Systematic Assessment | patient with emesis, abdominal pain and fever at 24 hour follow-up. Patient seen in the ED 1 week prior to infusion with similar symptoms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment | Patients with nausea with peripheral intravenous line insertion, prior to infusion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deryk Walsh, MD | University of Texas Southwestern | 2144566393 | deryk.walsh@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2017 | Dec 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 29, 2023 | Dec 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Total Propofol Dose | Total dose of propofol administered (mg/kg) | 60 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Pain Score 0-10 scale | 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 |
|
|
|
| Secondary | Total Propofol Dose | Total dose of propofol administered (mg/kg) | Posted | Mean | Standard Deviation | mg/kg | 60 minutes |
|
|
|
| 0 |
| 0 |
| 1 |
| 38 |
| 2 |
| 38 |
|
|
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| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| Title | Measurements |
|---|---|
|