Nitrous Oxide for Lumbar Puncture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lumbar Puncture in Emergency Under Nitrous OXide

NCT03941990

Pain Anxiety

UNKNOWN PHASE4

Effects of Subanesthetic Concentrations of Nitrous Oxide - 1

NCT00000249

COMPLETED PHASE2

Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers

NCT00643838

Dental Cares

COMPLETED PHASE3

Vapocoolant Spray for Reducing the Pain of Spinal Needle Insertion

NCT03175913

Low Back Pain

COMPLETED NA

Effectiveness of Nitrous Oxide 50% for Reducing Pain and Distress Associated with Needle-stick in Children

NCT03342079

Local Anesthetic Efficacy

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nitrous oxide

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

Group Type EXPERIMENTAL

Fixed 50:50 mixture of nitrous oxide and oxygen

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No