Caffeine Versus Placebo for Spinal Headaches

NCT ID: NCT00809627

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Post Dural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

IV caffeine with saline and opiate

Group Type EXPERIMENTAL

Caffeine

Intervention Type DRUG

Caffeine 500 mg IV

2

IV saline with opiate

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Normal saline

Interventions

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Caffeine

Caffeine 500 mg IV

Intervention Type DRUG

saline

Normal saline

Intervention Type DRUG

Other Intervention Names

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Treatment group Placebo control group

Eligibility Criteria

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Inclusion Criteria

* diagnosed with post dural puncture headache

Exclusion Criteria

* age \< 18
* pregnant
* allergic to caffeine
* cardiac or peripheral vascular disease
* uncontrolled hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Naval Medical Center, Portsmouth

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark A Kostic, MD

Role: STUDY_CHAIR

United States Naval Medical Center, Portsmouth

Marcelo Darabos, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, Portsmouth

Locations

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Emergency Department, Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CIP 2006 0051

Identifier Type: -

Identifier Source: org_study_id

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