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Lumbar Puncture in Emergency Under Nitrous OXide (LENOX)

Primary Purpose

Pain, Anxiety

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Fixed 50:50 mixture of nitrous oxide and oxygen
Placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Spinal puncture, Nitrous oxide, Pain, Anxiety, Emergency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitrous oxyde

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale
Proportion of patients with significant anxiety
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
Spinal puncture duration
Comparison of LP duration between both groups measured in minutes (from the beginning of gas inhalation to needle removal).
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.
Patient Satisfaction
overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions
Blinding quality
Assessment of blinding in clinical trials (according to Bang et al. 2004)
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)

Full Information

First Posted
May 2, 2019
Last Updated
February 18, 2020
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Inserm U1107, NeuroDol, Université d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT03941990
Brief Title
Lumbar Puncture in Emergency Under Nitrous OXide
Acronym
LENOX
Official Title
Impact of 50% Nitrous Oxide Inhalation on Pain Induced by Lumbar Puncture in Emergency: a Double-blind Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Inserm U1107, NeuroDol, Université d'Auvergne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Spinal puncture, Nitrous oxide, Pain, Anxiety, Emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2).
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitrous oxyde
Arm Type
Experimental
Arm Description
will inhale experimental treatment throughout the entire procedure (50% N2O - 50% 02)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
will inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.)
Intervention Type
Drug
Intervention Name(s)
Fixed 50:50 mixture of nitrous oxide and oxygen
Intervention Description
Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
inhale medical air (22% O2 - 78% N2)
Primary Outcome Measure Information:
Title
Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
Description
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?"
Time Frame
2-3 minutes after the end of gas inhalation
Secondary Outcome Measure Information:
Title
Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale
Description
Proportion of patients with significant anxiety
Time Frame
2-3 minutes after the end of gas inhalation
Title
Side effects
Description
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
Time Frame
From the beginning of gas inhalation to a minimum of 2 hours later
Title
Spinal puncture duration
Description
Comparison of LP duration between both groups measured in minutes (from the beginning of gas inhalation to needle removal).
Time Frame
2-3 minutes after the end of lumbar puncture
Title
Number of attempts before successful LP
Description
Comparison of number of attempts needed to get spinal fluid, defined as number of needle removals for a single exam.
Time Frame
2-3 minutes after the end of lumbar puncture
Title
Patient Satisfaction
Description
overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions
Time Frame
2-3 minutes after the end of gas inhalation
Title
Blinding quality
Description
Assessment of blinding in clinical trials (according to Bang et al. 2004)
Time Frame
2-3 minutes after the end of gas inhalation
Title
Induced cost
Description
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)
Time Frame
through study completion, an average 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE, Dr
Phone
(0)473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne Rhône-Alpes
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE, MD-PhD
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Xavier MOISSET, MD-PhD
First Name & Middle Initial & Last Name & Degree
Ludovic MIRAILLET, MD-PhD
First Name & Middle Initial & Last Name & Degree
Jeannot SCHMIDT, MD-PhD
First Name & Middle Initial & Last Name & Degree
Julien RACONNAT, MD-PhD
First Name & Middle Initial & Last Name & Degree
Farés MOUSTAFA, MD-PhD
First Name & Middle Initial & Last Name & Degree
Christine CARRIAS, MD-PhD
First Name & Middle Initial & Last Name & Degree
Nicolas DUBLANCHET, MD-PhD
First Name & Middle Initial & Last Name & Degree
Sandra TAZE, MD-PhD
First Name & Middle Initial & Last Name & Degree
Sonia AJIMI, MD-PhD
First Name & Middle Initial & Last Name & Degree
Marjolaine BOREL, MD-PhD
First Name & Middle Initial & Last Name & Degree
Marine MONDET, MD-PhD
First Name & Middle Initial & Last Name & Degree
Mathilde QUINTY, MD-PhD
First Name & Middle Initial & Last Name & Degree
Marie VALETTE, MD-PhD
First Name & Middle Initial & Last Name & Degree
Thomas FLEUCHOT, MD-PhD
First Name & Middle Initial & Last Name & Degree
Mélissa FLEURY, MD-PhD
First Name & Middle Initial & Last Name & Degree
Virginie GOULVIN, MD-PhD
First Name & Middle Initial & Last Name & Degree
Bastien MALOSSANE, MD-PhD
First Name & Middle Initial & Last Name & Degree
Vincent MARQUET, MD-PhD
First Name & Middle Initial & Last Name & Degree
Rémi MARTEL, MD-PhD
First Name & Middle Initial & Last Name & Degree
Marion PONCET, MD-PhD
First Name & Middle Initial & Last Name & Degree
Marie THOMAS, MD-PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26585197
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.
Results Reference
background
PubMed Identifier
15020033
Citation
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.
Results Reference
background
PubMed Identifier
10193230
Citation
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.
Results Reference
background
PubMed Identifier
17060584
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. doi: 10.1212/01.wnl.0000240054.40274.8a. Erratum In: Neurology. 2007 Feb 27;68(9):711. Yernitzky, D [corrected to Yarnitsky, D].
Results Reference
background
PubMed Identifier
23474866
Citation
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.
Results Reference
background
PubMed Identifier
27336667
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.
Results Reference
background
PubMed Identifier
27666149
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.
Results Reference
background

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Lumbar Puncture in Emergency Under Nitrous OXide

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