Lumbar Puncture in Emergency Under Nitrous OXide

Pain Clinical Trial

— LENOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941990
• Other study ID #: RBHP 2018 MOISSET
• Secondary ID: 2018-001296-20
• Status: Recruiting
• Phase: Phase 4
• Start date: November 27, 2019
• Est. completion date: September 2020

Study information

• Verified date: May 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE, Dr
• Phone: (0)473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: September 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Emergencies
• Pain

Intervention

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.

Other:
• Placebo
inhale medical air (22% O2 - 78% N2)

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne Rhône-Alpes

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Inserm U1107, NeuroDol, Université Clermont-Auvergne

Country where clinical trial is conducted

France, 

References & Publications (7)

Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. — View Citation

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. — View Citation

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. — View Citation

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]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Side effects	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blinding quality	Assessment of blinding in clinical trials (according to Bang et al. 2004)	2-3 minutes after the end of gas inhalation
Secondary	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