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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lumbar Puncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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N20

One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure.

Group Type EXPERIMENTAL

50:50 mixture of nitrous oxide/oxygen

Intervention Type DRUG

compressed air

The second group will inhale compressed air during the same period of time

Group Type OTHER

50:50 mixture of nitrous oxide/oxygen

Intervention Type DRUG

Interventions

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50:50 mixture of nitrous oxide/oxygen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No