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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002750-37 | Other Identifier | 2017-002750-37 |
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| Name | Class |
|---|---|
| University Hospital, Bordeaux | OTHER |
| Hospices Civils de Lyon | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous oxide | Experimental | will inhale experimental treatment (50% N2O - 50% O2) |
|
| Placebo | Placebo Comparator | will inhale medical air (22% O2 - 78% N2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed 50:50 mixture of nitrous oxide and oxygen | Drug | Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Analgesic efficacy measured with pain as a continuous variable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier MOISSET, MD-PhD | CHU Clermont-Ferrand, Inserm, Neuro-Dol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | Auvergne | 63003 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Université d'Auvergne |
| OTHER |
1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)
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double blinding. Gaz bottles are in undistinguishable boxes. Neither the patients nor the person doing the LP and the evaluation of pain and anxiety will know the treatment used
| Placebo | Other | inhale medical air (22% O2 - 78% N2) |
|
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. |
| 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 |
| 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 |
| 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 |
| 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 |
| Impact of age on side effects | incidence and type of side effects according to patient age | during the procedure and the 24 hours after |
| Induced cost | supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study | at day 1 |