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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001296-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Université d'Auvergne | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous oxyde | Experimental | will inhale experimental treatment throughout the entire procedure (50% N2O - 50% 02) |
|
| Placebo | Placebo Comparator | will inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.) |
|
| 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 |
|---|---|---|
| Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale | Maximal level of pain during lumbar puncture. The patient will be asked to circle the digit that best describes the maximal level of pain felt during the procedure. If the patient is too painful and/or is incapacitated, the collection notebook will be fulfilled by the care provider after asking the following question: "On a scale of 0 to 10, 0 being the absence of pain and 10 the maximal pain you can imagine, what is the digit best describing the maximal pain you felt during the procedure?" | 2-3 minutes after the end of gas inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale | Proportion of patients with significant anxiety | 2-3 minutes after the end of gas inhalation |
| Side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE, Dr | Contact | (0)473754963 | promo_interne_drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | Auvergne-Rhône-Alpes | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26585197 | Background | Herres J, Chudnofsky CR, Manur R, Damiron K, Deitch K. The use of inhaled nitrous oxide for analgesia in adult ED patients: a pilot study. Am J Emerg Med. 2016 Feb;34(2):269-73. doi: 10.1016/j.ajem.2015.10.038. Epub 2015 Oct 24. | |
| 15020033 | Background | Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D004630 | Emergencies |
| 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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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, 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
| Placebo | Other | inhale medical air (22% O2 - 78% N2) |
|
Every side effect reported by the patients attributable to gas inhalation during the procedure up to emergency service discharge. Presence, intensity and reversibility will be recorded
| From the beginning of gas inhalation to a minimum of 2 hours later |
| Spinal puncture duration | Comparison of LP duration between both groups measured in minutes (from the beginning of gas inhalation to needle removal). | 2-3 minutes after the end of lumbar puncture |
| Number of attempts before successful LP | Comparison of number of attempts needed to get spinal fluid, defined as number of needle removals for a single exam. | 2-3 minutes after the end of lumbar puncture |
| Patient Satisfaction | overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions | 2-3 minutes after the end of gas inhalation |
| Blinding quality | Assessment of blinding in clinical trials (according to Bang et al. 2004) | 2-3 minutes after the end of gas inhalation |
| Induced cost | supplementary cost induced by the use of nitrous oxide inhalation for a total of 88 patients throughout the study (gas and consumables such as masks and pipes) | through study completion, an average 4 months |
| 10193230 | Background | Koscielniak-Nielsen Z, Hesselbjerg L, Brushoj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22. doi: 10.1046/j.1365-2044.1998.00608.x. |
| 17060584 | Background | Lavi R, Yarnitsky D, Rowe JM, Weissman A, Segal D, Avivi I. Standard vs atraumatic Whitacre needle for diagnostic lumbar puncture: a randomized trial. Neurology. 2006 Oct 24;67(8):1492-4. doi: 10.1212/01.wnl.0000240054.40274.8a. |
| 23474866 | Background | Lukas A, Niederecker T, Gunther I, Mayer B, Nikolaus T. Self- and proxy report for the assessment of pain in patients with and without cognitive impairment: experiences gained in a geriatric hospital. Z Gerontol Geriatr. 2013 Apr;46(3):214-21. doi: 10.1007/s00391-013-0475-y. |
| 27336667 | Background | Moisset X, Ruet A, Brochet B, Planche V, Jaffeux P, Gilleron V, Ong N, Clavelou P. Who Performs Lumbar Puncture, How Many Do They Perform, How and Why? A Retrospective Study of 6,594 Cases. Eur Neurol. 2016;76(1-2):8-11. doi: 10.1159/000447452. Epub 2016 Jun 24. |
| 27666149 | Background | Moisset X, Sia MA, Pereira B, Taithe F, Dumont E, Bernard L, Clavelou P. Fixed 50:50 mixture of nitrous oxide and oxygen to reduce lumbar-puncture-induced pain: a randomized controlled trial. Eur J Neurol. 2017 Jan;24(1):46-52. doi: 10.1111/ene.13127. Epub 2016 Sep 25. |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |