Caffeine Versus Placebo for Spinal Headaches

October 28, 2013 updated by: Mark Kostic, United States Naval Medical Center, Portsmouth

A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Emergency Department, Naval Medical Center Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with post dural puncture headache

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
IV caffeine with saline and opiate
Drug: Caffeine
Caffeine 500 mg IV
Other Names:
  • Treatment group
Placebo Comparator: 2
IV saline with opiate
Drug: saline
Normal saline
Other Names:
  • Placebo control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain as measured by Visual Analog Scale
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, Portsmouth

Investigators

  • Study Chair: Mark A Kostic, MD, United States Naval Medical Center, Portsmouth
  • Principal Investigator: Marcelo Darabos, MD, United States Naval Medical Center, Portsmouth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP 2006 0051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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