Nitrous Oxide for Lumbar Puncture

Pain Clinical Trial

— NO for LP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03228628
• Other study ID #: CHU-342
• Secondary ID: 2017-002750-37
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 19, 2017
• Last updated: July 21, 2017
• Start date: October 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: July 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: September 1, 2019
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Hospices Civils de Lyon, Inserm U1107, NeuroDol, Université d'Auvergne, University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with significant pain	maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale	2-3 minutes after the end of gaz inhalation
Secondary	Proportion of patients with significant anxiety	maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale	2-3 minutes after the end of gaz inhalation
Secondary	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	2-3 minutes after the end of gaz inhalation.
Secondary	Anxiolytic efficacy measured with anxiety as a continuous variable	maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale	2-3 minutes after the end of gaz inhalation
Secondary	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	1 hour after the end of gaz inhalation
Secondary	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	1 hour after the end of gaz inhalation
Secondary	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	from the beginning of gaz inhalation to 24 hours later
Secondary	Impact of age on side effects	incidence and type of side effects according to patient age	during the procedure and the 24 hours after
Secondary	Induced cost	supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study	at day 1