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Caffeine Versus Placebo for Spinal Headaches

Primary Purpose

Post Dural Puncture Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine
saline
Sponsored by
United States Naval Medical Center, Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Dural Puncture Headache focused on measuring headache, caffeine, pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with post dural puncture headache

Exclusion Criteria:

  • age < 18
  • pregnant
  • allergic to caffeine
  • cardiac or peripheral vascular disease
  • uncontrolled hypertension

Sites / Locations

  • Emergency Department, Naval Medical Center Portsmouth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

IV caffeine with saline and opiate

IV saline with opiate

Outcomes

Primary Outcome Measures

Pain as measured by Visual Analog Scale

Secondary Outcome Measures

Full Information

First Posted
December 16, 2008
Last Updated
October 28, 2013
Sponsor
United States Naval Medical Center, Portsmouth
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1. Study Identification

Unique Protocol Identification Number
NCT00809627
Brief Title
Caffeine Versus Placebo for Spinal Headaches
Official Title
A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, Portsmouth

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache").
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Dural Puncture Headache
Keywords
headache, caffeine, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
IV caffeine with saline and opiate
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
IV saline with opiate
Intervention Type
Drug
Intervention Name(s)
Caffeine
Other Intervention Name(s)
Treatment group
Intervention Description
Caffeine 500 mg IV
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
Placebo control group
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Pain as measured by Visual Analog Scale
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with post dural puncture headache Exclusion Criteria: age < 18 pregnant allergic to caffeine cardiac or peripheral vascular disease uncontrolled hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Kostic, MD
Organizational Affiliation
United States Naval Medical Center, Portsmouth
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcelo Darabos, MD
Organizational Affiliation
United States Naval Medical Center, Portsmouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department, Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States

12. IPD Sharing Statement

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Caffeine Versus Placebo for Spinal Headaches

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