Caffeine Versus Placebo for Spinal Headaches
This study has been completed.
Sponsor:
United States Naval Medical Center, Portsmouth
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT00809627
First received: December 16, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 16, 2008 | ||||||||
| Last Updated Date | December 16, 2008 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain as measured by Visual Analog Scale [ Time Frame: 60 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Caffeine Versus Placebo for Spinal Headaches | ||||||||
| Official Title ICMJE | A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department | ||||||||
| Brief Summary | Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache"). |
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| Detailed Description | Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Post Dural Puncture 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 | Completed | ||||||||
| Enrollment ICMJE | 21 | ||||||||
| Completion Date | May 2008 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00809627 | ||||||||
| Other Study ID Numbers ICMJE | CIP 2006 0051 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Mark Kostic, MD, Naval Medical Center Portsmouth | ||||||||
| Study Sponsor ICMJE | United States Naval Medical Center, Portsmouth | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | United States Naval Medical Center, Portsmouth | ||||||||
| Verification Date | December 2008 | ||||||||
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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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