NCT00809627

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

December 16, 2008

Last Update Submit

August 12, 2025

Conditions

Post Dural Puncture Headache

Keywords

headachecaffeinepain

Outcome Measures

Primary Outcomes (1)

  • Pain as measured by Visual Analog Scale

    60 minutes

Study Arms (2)

1

EXPERIMENTAL

IV caffeine with saline and opiate

Drug: Caffeine

2

PLACEBO COMPARATOR

IV saline with opiate

Drug: saline

Interventions

CaffeineDRUG

Caffeine 500 mg IV

Also known as: Treatment group
1
salineDRUG

Normal saline

Also known as: Placebo control group
2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with post dural puncture headache

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture HeadacheHeadachePain

Interventions

CaffeineSodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mark A Kostic, MD

    United States Naval Medical Center, Portsmouth

    STUDY CHAIR

  • Marcelo Darabos, MD

    United States Naval Medical Center, Portsmouth

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations

US(1)