Caffeine Versus Placebo for Spinal Headaches | NCT00809627

Studies
Caffeine Versus Placebo for Spinal Headaches

NCT00809627

Sponsor

United States Naval Medical Center, Portsmouth

Status

Withdrawn

Last Update Posted

Aug 15, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Post Dural Puncture Headache

Interventions

Caffeine
saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never initiated

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Dec 16, 2008

First Submission Date that Met QC Criteria

Dec 16, 2008

First Posted Date

Dec 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2025

Last Update Posted Date

Aug 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	IV caffeine with saline and opiate	Drug: Caffeine
2	Placebo Comparator	IV saline with opiate	Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caffeine	Drug	Caffeine 500 mg IV	1	Treatment group

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark A Kostic, MD	United States Naval Medical Center, Portsmouth	Study Chair
Marcelo Darabos, MD	United States Naval Medical Center, Portsmouth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency Department, Naval Medical Center Portsmouth		Portsmouth	Virginia	23708	United States

Condition Browse Module

MeSH Terms

ID	Term
D051299	Post-Dural Puncture Headache
D006261	Headache
D010146	Pain

Ancestor Terms

ID	Term
D051271	Headache Disorders, Secondary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002110	Caffeine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones

Browse Leaves

Not provided

Browse Branches

Not provided