Clinical trial NCT03228628: Nitrous Oxide for Lumbar Puncture
Official title: Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Anxiety
Keywords: Spinal puncture
Pain
Anxiety
Nitrous oxyde
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
name: Hospices Civils de Lyon
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Université d'Auvergne
First posted: 2017-07-25
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with significant pain
timeFrame: 2-3 minutes after the end of gaz inhalation
Secondary outcomes:
measure: Proportion of patients with significant anxiety
timeFrame: 2-3 minutes after the end of gaz inhalation
measure: Analgesic efficacy measured with pain as a continuous variable
timeFrame: 2-3 minutes after the end of gaz inhalation.
measure: Anxiolytic efficacy measured with anxiety as a continuous variable
timeFrame: 2-3 minutes after the end of gaz inhalation
measure: Pain during the procedure evaluated one hour after the end of the lumbar puncture
timeFrame: 1 hour after the end of gaz inhalation
measure: Anxiety during the procedure evaluated one hour after the end of the lumbar puncture
timeFrame: 1 hour after the end of gaz inhalation
measure: Side effects
timeFrame: from the beginning of gaz inhalation to 24 hours later
measure: Impact of age on side effects
timeFrame: during the procedure and the 24 hours after
measure: Induced cost
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: CHU Clermont-Ferrand, Inserm, Neuro-Dol
name: Xavier MOISSET, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: