NCT03228628

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Oct 2017

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

July 19, 2017

Last Update Submit

July 21, 2017

Conditions

PainAnxiety

Keywords

Spinal puncturePainAnxietyNitrous oxyde

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with significant pain

    maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale

    2-3 minutes after the end of gaz inhalation

Secondary Outcomes (8)

  • Proportion of patients with significant anxiety

    2-3 minutes after the end of gaz inhalation

  • Analgesic efficacy measured with pain as a continuous variable

    2-3 minutes after the end of gaz inhalation.

  • Anxiolytic efficacy measured with anxiety as a continuous variable

    2-3 minutes after the end of gaz inhalation

  • Pain during the procedure evaluated one hour after the end of the lumbar puncture

    1 hour after the end of gaz inhalation

  • Anxiety during the procedure evaluated one hour after the end of the lumbar puncture

    1 hour after the end of gaz inhalation

  • +3 more secondary outcomes

Study Arms (2)

Nitrous oxide

EXPERIMENTAL

will inhale experimental treatment (50% N2O - 50% O2)

Drug: Fixed 50:50 mixture of nitrous oxide and oxygen

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Fixed 50:50 mixture of nitrous oxide and oxygenDRUG

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

Nitrous oxide
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients coming in the neurology department for a lumbar puncture
  • at least 18
  • no previous use of nitrous oxide

You may not qualify if:

  • contra-indication to nitrous oxide use
  • Body Mass Index\>35
  • Mini Mental State Examination \<24/30
  • Temperature \>38°C
  • Confusion
  • Patient unable to communicate verbaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Xavier MOISSET, MD-PhD

    CHU Clermont-Ferrand, Inserm, Neuro-Dol

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blinding. Gaz bottles are in undistinguishable boxes. Neither the patients nor the person doing the LP and the evaluation of pain and anxiety will know the treatment used
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 25, 2017

Study Start

October 1, 2017

Primary Completion

June 6, 2018

Study Completion

September 1, 2019

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

FR(1)