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

Study Overview
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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.

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.

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

Conditions
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Lumbar Puncture

Intervention / Treatment
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* Drug: 50:50 mixture of nitrous oxide/oxygen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N20<br>One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. | Drug: 50:50 mixture of nitrous oxide/oxygen<br> <br> |
| Other: compressed air<br>The second group will inhale compressed air during the same period of time | Drug: 50:50 mixture of nitrous oxide/oxygen<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal pain level during the procedure |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal anxiety level during the procedure |  | at day 1 | 
| Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI) |  | at day 1 | 
| Proportion of patients presenting side effects |  | at day 1 | 
| Total duration of the lumbar puncture |  | at day 1 | 
| Proportion of patients that would accept another lumbar puncture in the same conditions |  | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar puncture, Adults, Nitrous oxide, Procedural pain, Procedural anxiety