Lumbar Puncture in Emergency Under Nitrous OXide

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-27

Study Completion Date

2020-09-30

Brief Summary

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Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. The goal of this trial is to confirm these results in a more heterogeneous group of patients having a LP, in an emergency setting.

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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 only been investigated in a scheduled setting.Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.

Patients with urgent 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. 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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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

double blinding, gas bottles are in undistinguishable boxes, and each gas mask will be filled with odorous ink masking the sweet flavour of N2O. Neither the patient nor the person doing the LP and/or the evaluation of pain and anxiety will know the treatment used

Study Groups

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Nitrous oxyde

will inhale experimental treatment throughout the entire procedure (50% N2O - 50% 02)

Group Type EXPERIMENTAL

Fixed 50:50 mixture of nitrous oxide and oxygen

Intervention Type DRUG

Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.

Placebo

will inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients coming in emergency service who need a lumbar puncture in emergency for a diagnostic purpose
* at least 18
* affiliated to the French state healthcare insurance system
* able to give consent to participation

Exclusion Criteria

* Previous use of nitrous oxide (medical or recreational)
* Contra-indication to nitrous oxide use
* Face mask phobia
* Stage II obesity (BMI \> 35)
* Hemodynamic instability and/or any case when coagulation results cannot be waited
* Cognitive condition defined by a previous Mini Mental State Examination \< 24/30
* Confusion or any consciousness disorder that might interfere with judgment or consent
* Patient unable to communicate verbally
* Patient placed under a legal protection measure (tutorship, curatorship or a mandate)
* Any medical condition that might contra-indicate medical research, in physician's opinion

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No