Caffeine Versus Placebo for Spinal Headaches

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Kostic, United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT00809627
First received: December 16, 2008
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Post Dural Puncture Headache
Drug: Caffeine
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • Pain as measured by Visual Analog Scale [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with post dural puncture headache

Exclusion Criteria:

  • age < 18
  • pregnant
  • allergic to caffeine
  • cardiac or peripheral vascular disease
  • uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809627

Locations
United States, Virginia
Emergency Department, Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
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
  More Information

No publications provided

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
Study First Received: December 16, 2008
Last Updated: October 28, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by United States Naval Medical Center, Portsmouth:
headache
caffeine
pain

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

ClinicalTrials.gov processed this record on October 23, 2014