Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Propofol, a general anesthetic, has been suggested to be effective for the treatment of migraine headaches in adults when used in subanesthetic doses (lower doses than those used for anesthesia or sedation). Initial retrospective review of the investigators experience with propofol for migraine in children suggests that it is safe and may be more effective than standard treatments used in the emergency department. The investigators retrospective series had a small subject population and a larger study is needed to compare propofol to current available treatments.
Standard treatment currently consists of a "cocktail" of medications that include anti-nausea medicines (metoclopramide and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects assigned to the experimental group (Propofol) will receive the same intravenous fluids and up to five doses of propofol. All subjects will undergo assessment of their pain (self-rated on a scale from 0-10) before and after treatment. Post-visit clinical data will be collected from the subject's medical record and subjects will be called by telephone 24-48 hours after discharge from the emergency department to ask how they are doing and whether they required any additional treatments such as home medications or by other medical professionals other than OHSU.
There has been little advancement in abortive migraine therapies in recent decades, and few proven treatments exist for acute migraine, particularly in children. Propofol, a general anesthetic, has been suggested to be effective for the treatment of migraine headaches in adults when used in subanesthetic doses (lower doses than those used for anesthesia or sedation). Initial retrospective review of the investigators experience with propofol for migraine in children suggests that it is safe and may be more effective than standard treatments used in the emergency department. The investigators retrospective series had a small subject population and a larger study is needed to compare propofol to current available treatments.
All subjects presenting to the pediatric emergency department with signs/symptoms of migraine headache will be screened for the study. Subjects who are eligible will be provided information about the study and consent/assent forms from a member of the research team, and asked whether they are interested in participating.
All study subjects will receive acetaminophen (Tylenol) or ibuprofen (Motrin) for their headache if they have not already tried these first-line treatments at home; those with persistent symptoms requiring further treatment who consent to participate in the study will be randomized to receive either standard treatment or propofol. Standard treatment currently consists of a "cocktail" of medications that include anti-nausea medicines (metoclopramide and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects assigned to the experimental group (Propofol) will receive the same intravenous fluids and up to five doses of propofol. All subjects will undergo assessment of their pain (self-rated on a scale from 0-10) before and after treatment. During treatment they will have close monitoring of their vital signs. No additional laboratory tests or procedures are involved. Post-visit clinical data will be collected from the subject's medical record and subjects will be called by telephone 24-48 hours after discharge from the emergency department to ask how they are doing and whether they required any additional treatments such as home medications or by other medical professionals other than OHSU.
The study data will be presented in summary tables that outline subjects' clinical presentation prior to treatments, and response to study drug during their visit. The main variables of interest include effectiveness (determined as a reduction in self-reported pain score), length of stay in the pediatric emergency department, recurrent headache requiring emergency treatment within 24 hours and whether any adverse effects occur. These will be compared between the 2 study groups with basic statistics.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment Group | Experimental | Propofol at subanesthetic dose via IV push |
|
| Standard Treatment Group | Active Comparator | Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Assessed Pain | Percent pain change after initial treatment using 10 point VAS scale | 15 minutes after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Rebound Headache at 24 Hour Follow-up Phone Call | Percentage of subjects reporting recurrence of headache with pain greater than at time of discharge from Emergency Department | 24 hours |
| Emergency Department Length of Stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Garth D Meckler, MD, MSHS | Oregon Health and Science University | Principal Investigator |
| David Sheridan, MD | sheridda@ohsu.edu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Treatment Group | Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses Total enrollment = 37 subjects |
| FG001 | Standard Treatment Group | Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide Total enrollment = 37 subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 patient excluded for repeat visit from ST arm 7 patients excluded for repeat visit from Experimental arm
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Treatment Group | Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses |
| BG001 | Standard Treatment Group |
| 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 | Change in Self-Assessed Pain | Percent pain change after initial treatment using 10 point VAS scale | Posted | Number | percentage change | 15 minutes after administration |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Treatment Group | Propofol at subanesthetic dose via IV push Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extrapyramidal Symptoms | Nervous system disorders | Systematic Assessment | Extrapyramidal symptoms |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Sheridan | Oregon Health & Science University | 503 494-8311 | sheridda@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D018492 | Dopamine Antagonists |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Treatment | Drug | Ketorolac, Diphenhydramine and Metoclopramide |
|
|
Length of stay from administration of medication to Emergency Department discharge in minutes
| Duration of stay in Emergency Department in Minutes |
Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion
Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Rebound Headache at 24 Hour Follow-up Phone Call | Percentage of subjects reporting recurrence of headache with pain greater than at time of discharge from Emergency Department | Percentage of participants | Posted | Number | Percentage of subjects reporting rebound | 24 hours |
|
|
|
| Secondary | Emergency Department Length of Stay | Length of stay from administration of medication to Emergency Department discharge in minutes | Posted | Median | Full Range | Minutes | Duration of stay in Emergency Department in Minutes |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Standard Treatment Group | Metaclopramide in combination with ketorolac and diphenhydramine via IV infusion Standard Treatment: Ketorolac, Diphenhydramine and Metoclopramide | 0 | 36 | 0 | 36 | 3 | 36 |
|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Transient self-resolved hypoxia to 89% |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D015259 | Dopamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |