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

Phase 4

• Conditions: Lumbar Puncture

• Registration Number: NCT02243826
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-09-21
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximal pain level during the procedure	at day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France