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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03941990
Recruitment Status Recruiting
First Posted May 8, 2019
Last update posted February 20, 2020
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.
|Experimental: Nitrous oxyde
will inhale experimental treatment throughout the entire procedure (50% N2O - 50% 02)
Drug: 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.
|Placebo Comparator: Placebo
will inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.)
inhale medical air (22% O2 - 78% N2)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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
- 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
Contact: Lise LACLAUTRE, Dr (0)473754963 firstname.lastname@example.org
France, Auvergne Rhône-Alpes
CHU de Clermont-Ferrand
University Hospital, Clermont-Ferrand
Inserm U1107, NeuroDol
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.
Koscielniak-Nielsen Z, Hesselbjerg L, Brushøj 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.
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. Erratum in: Neurology. 2007 Feb 27;68(9):711. Yernitzky, D [corrected to Yarnitsky, D].
Lukas A, Niederecker T, Günther 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.
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.
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.