NCT03228628

Nitrous Oxide for Lumbar Puncture

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Anxiety

Interventions

Type	Name	Description
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.
OTHER	Placebo	inhale medical air (22% O2 - 78% N2)

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-06-06
• Completion: 2019-09-01
• First posted: 2017-07-25
• Last updated: 2017-07-25

Locations

1 site across 1 country: France