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

Lumbar Puncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243826
• Other study ID #: CHU-206
• Secondary ID: 2014-001452-28
• Status: Recruiting
• Phase: Phase 4
• First received: September 16, 2014
• Last updated: September 18, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.

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 never been investigated properly.

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: Recruiting
• Enrollment: 66
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients coming in the neurology department for a scheduled lumbar puncture

• 18 to 60 years.

• no previous use of nitrous oxide

Exclusion Criteria:

• contra-indication to nitrous oxide use

• Body Mass Index>35

• Mini Mental State Examination <26/30

• Temperature >38°C

• Confusion

• Patient unable to communicate verbaly

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Puncture

Intervention

Drug:
• 50:50 mixture of nitrous oxide/oxygen

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal pain level during the procedure		at day 1	Yes
Secondary	Maximal anxiety level during the procedure		at day 1	Yes
Secondary	Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)		at day 1	Yes
Secondary	Proportion of patients presenting side effects		at day 1	Yes
Secondary	Total duration of the lumbar puncture		at day 1	Yes
Secondary	Proportion of patients that would accept another lumbar puncture in the same conditions		at day 1	Yes