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Nitrous Oxide for Lumbar Puncture

NCT03228628 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2017-07-25

No results posted yet for this study

Summary

Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot single-center study, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this multi-center trial is to confirm these results in a larger and more heterogeneous group of patients having a LP.

Conditions

Interventions

DRUG

Fixed 50:50 mixture of nitrous oxide and oxygen

Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.

OTHER

Placebo

inhale medical air (22% O2 - 78% N2)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Université d'Auvergne

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Xavier MOISSET, MD-PhD · CHU Clermont-Ferrand, Inserm, Neuro-Dol

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-06-06
Completion
2019-09-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228628 on ClinicalTrials.gov