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Caffeine Versus Placebo for Spinal Headaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00809627
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : October 29, 2013
Information provided by (Responsible Party):
Mark Kostic, United States Naval Medical Center, Portsmouth

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

Condition or disease Intervention/treatment
Post Dural Puncture Headache Drug: Caffeine Drug: saline

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  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department
Study Start Date : January 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Headache
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Pain as measured by Visual Analog Scale [ Time Frame: 60 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosed with post dural puncture headache

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809627

United States, Virginia
Emergency Department, Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
Study Chair: Mark A Kostic, MD United States Naval Medical Center, Portsmouth
Principal Investigator: Marcelo Darabos, MD United States Naval Medical Center, Portsmouth

Responsible Party: Mark Kostic, Faculty physician, United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier: NCT00809627     History of Changes
Other Study ID Numbers: CIP 2006 0051
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by Mark Kostic, United States Naval Medical Center, Portsmouth:

Additional relevant MeSH terms:
Post-Dural Puncture Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents