Nitrous Oxide for Lumbar Puncture (NO for LP)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 4

Conditions: Anxiety; Pain

Treatments: Other: Placebo; Drug: Fixed 50:50 mixture of nitrous oxide and oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT03228628

2017-002750-37 (Other Identifier)

CHU-342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups, including a placebo group

Nitrous oxide

Experimental group

Description:

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

Treatment:

Drug: Fixed 50:50 mixture of nitrous oxide and oxygen

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo