NCT02243826

Brief Summary

This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.

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
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2014

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

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

September 16, 2014

Last Update Submit

September 18, 2015

Conditions

Lumbar Puncture

Keywords

Lumbar punctureAdultsNitrous oxideProcedural painProcedural anxiety

Outcome Measures

Primary Outcomes (1)

  • Maximal pain level during the procedure

    at day 1

Secondary Outcomes (5)

  • Maximal anxiety level during the procedure

    at day 1

  • Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)

    at day 1

  • Proportion of patients presenting side effects

    at day 1

  • Total duration of the lumbar puncture

    at day 1

  • Proportion of patients that would accept another lumbar puncture in the same conditions

    at day 1

Study Arms (2)

N20

EXPERIMENTAL

One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure.

Drug: 50:50 mixture of nitrous oxide/oxygen

compressed air

OTHER

The second group will inhale compressed air during the same period of time

Drug: 50:50 mixture of nitrous oxide/oxygen

Interventions

50:50 mixture of nitrous oxide/oxygenDRUG
N20compressed air

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients coming in the neurology department for a scheduled lumbar puncture
  • to 60 years.
  • 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 \<26/30
  • 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, 63003, France

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Interventions

Oxygen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Pierre CLAVELOU

    University Hospital, Clermont-Ferrand

    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, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 18, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations

FR(1)