Lumbar Puncture in Emergency Under Nitrous OXide

NCT03941990 | Unknown Phase 4

• 2 other identifiers: RBHP 2018 MOISSET2018-001296-20
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Anxiety

Keywords

Spinal puncture; Nitrous oxide; Pain; Anxiety; Emergency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale

  2-3 minutes after the end of gas inhalation

• Side effects

  From the beginning of gas inhalation to a minimum of 2 hours later

• Spinal puncture duration

  2-3 minutes after the end of lumbar puncture

• Number of attempts before successful LP

  2-3 minutes after the end of lumbar puncture

• Patient Satisfaction

  2-3 minutes after the end of gas inhalation

Study Arms (2)

Nitrous oxyde

EXPERIMENTAL

will inhale experimental treatment throughout the entire procedure (50% N2O - 50% 02)

Drug: Fixed 50:50 mixture of nitrous oxide and oxygen

Placebo

PLACEBO COMPARATOR

will inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.)

Other: Placebo

Interventions

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.

Nitrous oxyde

Placebo OTHER

inhale medical air (22% O2 - 78% N2)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Université d'Auvergne: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 26585197 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.

  PMID: 15020033 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.

  PMID: 10193230 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.

  PMID: 17060584 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.

  PMID: 23474866 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.

  PMID: 27336667 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.

  PMID: 27666149 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Emergencies

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Central Study Contacts

Lise LACLAUTRE, Dr

CONTACT

(0)473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2).

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 8, 2019
• Study Start: November 27, 2019
• Primary Completion: April 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 20, 2020

Record last verified: 2019-05

Locations

FR (1)