Caffeine Versus Placebo for Spinal Headaches

Post Dural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809627
• Other study ID #: CIP 2006 0051
• Status: Completed
• Phase: N/A
• First received: December 16, 2008
• Last updated: October 28, 2013
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: October 2013
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• diagnosed with post dural puncture headache

Exclusion Criteria:

• age < 18

• pregnant

• allergic to caffeine

• cardiac or peripheral vascular disease

• uncontrolled hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Post Dural Puncture Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• Caffeine
Caffeine 500 mg IV
• saline
Normal saline

Locations

Country	Name	City	State
United States	Emergency Department, Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured by Visual Analog Scale		60 minutes	No