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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.
inhale medical air (22% O2 - 78% N2)
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France
Proportion of patients with significant pain
maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
Time frame: 2-3 minutes after the end of gaz inhalation
Proportion of patients with significant anxiety
maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: at day 1