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Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial

Primary Purpose

Lumbar Puncture

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
50:50 mixture of nitrous oxide/oxygen
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Puncture focused on measuring Lumbar puncture, Adults, Nitrous oxide, Procedural pain, Procedural anxiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients coming in the neurology department for a scheduled lumbar puncture
  • 18 to 60 years.
  • no previous use of nitrous oxide

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

N20

compressed air

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maximal pain level during the procedure

Secondary Outcome Measures

Maximal anxiety level during the procedure
Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)
Proportion of patients presenting side effects
Total duration of the lumbar puncture
Proportion of patients that would accept another lumbar puncture in the same conditions

Full Information

First Posted
September 16, 2014
Last Updated
September 18, 2015
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02243826
Brief Title
Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial
Official Title
Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.
Detailed Description
Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a century. Nonetheless, it's use during lumbar puncture in adults has never been investigated properly. Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture. Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. The second group will inhale compressed air during the same period of time. Neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding). The maximal pain level that occurred during the procedure will be evaluated on a Numerical Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Puncture
Keywords
Lumbar puncture, Adults, Nitrous oxide, Procedural pain, Procedural anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N20
Arm Type
Experimental
Arm Description
One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure.
Arm Title
compressed air
Arm Type
Other
Arm Description
The second group will inhale compressed air during the same period of time
Intervention Type
Drug
Intervention Name(s)
50:50 mixture of nitrous oxide/oxygen
Primary Outcome Measure Information:
Title
Maximal pain level during the procedure
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Maximal anxiety level during the procedure
Time Frame
at day 1
Title
Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)
Time Frame
at day 1
Title
Proportion of patients presenting side effects
Time Frame
at day 1
Title
Total duration of the lumbar puncture
Time Frame
at day 1
Title
Proportion of patients that would accept another lumbar puncture in the same conditions
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients coming in the neurology department for a scheduled lumbar puncture 18 to 60 years. no previous use of nitrous oxide Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre CLAVELOU
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

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Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial

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