Clinical trial NCT03941990: Lumbar Puncture in Emergency Under Nitrous OXide
Official title: Impact of 50% Nitrous Oxide Inhalation on Pain Induced by Lumbar Puncture in Emergency: a Double-blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Anxiety
Keywords: Spinal puncture
Nitrous oxide
Pain
Anxiety
Emergency
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Université d'Auvergne
First posted: 2019-05-08
Enrollment: 88
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 scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. The goal of this trial is to confirm these results in a more heterogeneous group of patients having a LP, in an emergency setting.

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 scheduled setting.Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.

Patients with urgent 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. 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:

* Adult patients coming in emergency service who need a lumbar puncture in emergency for a diagnostic purpose
* at least 18
* affiliated to the French state healthcare insurance system
* able to give consent to participation

Exclusion Criteria:

* Previous use of nitrous oxide (medical or recreational)
* Contra-indication to nitrous oxide use
* Face mask phobia
* Stage II obesity (BMI \> 35)
* Hemodynamic instability and/or any case when coagulation results cannot be waited
* Cognitive condition defined by a previous Mini Mental State Examination \< 24/30
* Confusion or any consciousness disorder that might interfere with judgment or consent
* Patient unable to communicate verbally
* Patient placed under a legal protection measure (tutorship, curatorship or a mandate)
* Any medical condition that might contra-indicate medical research, in physician's opinion

Primary outcomes:
measure: Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
timeFrame: 2-3 minutes after the end of gas inhalation
Secondary outcomes:
measure: Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale
timeFrame: 2-3 minutes after the end of gas inhalation
measure: Side effects
timeFrame: From the beginning of gas inhalation to a minimum of 2 hours later
measure: Spinal puncture duration
timeFrame: 2-3 minutes after the end of lumbar puncture
measure: Number of attempts before successful LP
timeFrame: 2-3 minutes after the end of lumbar puncture
measure: Patient Satisfaction
timeFrame: 2-3 minutes after the end of gas inhalation
measure: Blinding quality
timeFrame: 2-3 minutes after the end of gas inhalation
measure: Induced cost
timeFrame: through study completion, an average 4 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne Rhône-Alpes
Study officials:
References:
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citation: Lukas A, Niederecker T, Gunther I, Mayer B, Nikolaus T. Self- and proxy report for the assessment of pain in patients with and without cognitive impairment: experiences gained in a geriatric hospital. Z Gerontol Geriatr. 2013 Apr;46(3):214-21. doi: 10.1007/s00391-013-0475-y.
citation: Moisset X, Ruet A, Brochet B, Planche V, Jaffeux P, Gilleron V, Ong N, Clavelou P. Who Performs Lumbar Puncture, How Many Do They Perform, How and Why? A Retrospective Study of 6,594 Cases. Eur Neurol. 2016;76(1-2):8-11. doi: 10.1159/000447452. Epub 2016 Jun 24.
citation: Moisset X, Sia MA, Pereira B, Taithe F, Dumont E, Bernard L, Clavelou P. Fixed 50:50 mixture of nitrous oxide and oxygen to reduce lumbar-puncture-induced pain: a randomized controlled trial. Eur J Neurol. 2017 Jan;24(1):46-52. doi: 10.1111/ene.13127. Epub 2016 Sep 25.