Low-dose Propofol for Pediatric Migraine
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 22, 2012 | ||||||||
| Last Updated Date | October 12, 2012 | ||||||||
| Start Date ICMJE | November 2012 | ||||||||
| Estimated Primary Completion Date | November 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction in Self-Assessed Pain [ Time Frame: 15 minutes after administration ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01604785 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: Continuous every 5 minutes ] [ Designated as safety issue: Yes ] Monitoring of all patient vital signs including HR, BP, POX, RR and mental status |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Low-dose Propofol for Pediatric Migraine | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Migraine Headache | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||
| Estimated Completion Date | January 2016 | ||||||||
| Estimated Primary Completion Date | November 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 7 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01604785 | ||||||||
| Other Study ID Numbers ICMJE | Meckler01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Garth Meckler, Oregon Health and Science University | ||||||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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