Nitrous Oxide for Lumbar Puncture (NO for LP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Anxiety
• Intervention / Treatment: Drug: Fixed 50:50 mixture of nitrous oxide and oxygen; Other: Placebo

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 only been investigated in a single-centre study.

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 Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • CHU de Clermont-Ferrand
      • Sub-Investigator: Sandra VUKUSIC, MD-PhD
      • Sub-Investigator: Bruno BROCHET, MD-PhD
      • Sub-Investigator: Pierre CLAVELOU, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nitrous oxide; will inhale experimental treatment (50% N2O - 50% O2)	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.
PLACEBO_COMPARATOR: Placebo; will inhale medical air (22% O2 - 78% N2)	Other: Placebo; inhale medical air (22% O2 - 78% N2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with significant anxiety	maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale	2-3 minutes after the end of gaz inhalation
Analgesic efficacy measured with pain as a continuous variable	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.
Anxiolytic efficacy measured with anxiety as a continuous variable	maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale	2-3 minutes after the end of gaz inhalation
Pain during the procedure evaluated one hour after the end of the lumbar puncture	maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale	1 hour after the end of gaz inhalation
Anxiety during the procedure evaluated one hour after the end of the lumbar puncture	maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale	1 hour after the end of gaz inhalation
Side effects	every side effects reported by the patients during the procedure up to 24 hours after the lumbar puncture, including post-puncture puncture headache	from the beginning of gaz inhalation to 24 hours later
Impact of age on side effects	incidence and type of side effects according to patient age	during the procedure and the 24 hours after
Induced cost	supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Hospices Civils de Lyon; University Hospital, Bordeaux; Université d'Auvergne; Inserm U1107, NeuroDol
• Investigators: Principal Investigator: Xavier MOISSET, MD-PhD, CHU Clermont-Ferrand, Inserm, Neuro-Dol

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2017
• Primary Completion (ANTICIPATED): June 6, 2018
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (ACTUAL): July 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Spinal puncture; Nitrous oxyde
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: CHU-342; 2017-002750-37 (OTHER: 2017-002750-37)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No