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出境医 / 临床实验 / Lumbar Puncture in Emergency Under Nitrous OXide (LENOX)

Lumbar Puncture in Emergency Under Nitrous OXide (LENOX)

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.

Condition or disease Intervention/treatment Phase
Pain Anxiety Drug: Fixed 50:50 mixture of nitrous oxide and oxygen Other: Placebo Phase 4

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2).
Masking: Triple (Participant, Care Provider, Outcomes 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
Primary Purpose: Treatment
Official Title: Impact of 50% Nitrous Oxide Inhalation on Pain Induced by Lumbar Puncture in Emergency: a Double-blind Randomized Controlled Trial.
Actual Study Start Date : November 27, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
Arm Intervention/treatment
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.)
 Other: Placebo
inhale medical air (22% O2 - 78% N2)
Outcome Measures
Primary Outcome Measures :
  1. Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale [ Time Frame: 2-3 minutes after the end of gas inhalation ]
    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 :
  1. Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale [ Time Frame: 2-3 minutes after the end of gas inhalation ]
    Proportion of patients with significant anxiety

  2. Side effects [ Time Frame: From the beginning of gas inhalation to a minimum of 2 hours later ]
    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

  3. Spinal puncture duration [ Time Frame: 2-3 minutes after the end of lumbar puncture ]
    Comparison of LP duration between both groups measured in minutes (from the beginning of gas inhalation to needle removal).

  4. Number of attempts before successful LP [ Time Frame: 2-3 minutes after the end of lumbar puncture ]
    Comparison of number of attempts needed to get spinal fluid, defined as number of needle removals for a single exam.

  5. Patient Satisfaction [ Time Frame: 2-3 minutes after the end of gas inhalation ]
    overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions

  6. Blinding quality [ Time Frame: 2-3 minutes after the end of gas inhalation ]
    Assessment of blinding in clinical trials (according to Bang et al. 2004)

  7. Induced cost [ Time Frame: through study completion, an average 4 months ]
    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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lise LACLAUTRE, Dr (0)473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne Rhône-Alpes, France, 63000
Contact: Lise LACLAUTRE, MD-PhD       promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Xavier MOISSET, MD-PhD         
Sub-Investigator: Ludovic MIRAILLET, MD-PhD         
Sub-Investigator: Jeannot SCHMIDT, MD-PhD         
Sub-Investigator: Julien RACONNAT, MD-PhD         
Sub-Investigator: Farés MOUSTAFA, MD-PhD         
Sub-Investigator: Christine CARRIAS, MD-PhD         
Sub-Investigator: Nicolas DUBLANCHET, MD-PhD         
Sub-Investigator: Sandra TAZE, MD-PhD         
Sub-Investigator: Sonia AJIMI, MD-PhD         
Sub-Investigator: Marjolaine BOREL, MD-PhD         
Sub-Investigator: Marine MONDET, MD-PhD         
Sub-Investigator: Mathilde QUINTY, MD-PhD         
Sub-Investigator: Marie VALETTE, MD-PhD         
Sub-Investigator: Thomas FLEUCHOT, MD-PhD         
Sub-Investigator: Mélissa FLEURY, MD-PhD         
Sub-Investigator: Virginie GOULVIN, MD-PhD         
Sub-Investigator: Bastien MALOSSANE, MD-PhD         
Sub-Investigator: Vincent MARQUET, MD-PhD         
Sub-Investigator: Rémi MARTEL, MD-PhD         
Sub-Investigator: Marion PONCET, MD-PhD         
Sub-Investigator: Marie THOMAS, MD-PhD         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Inserm U1107, NeuroDol
Université d'Auvergne
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE November 27, 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		Maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale [ Time Frame: 2-3 minutes after the end of gas inhalation ]
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?"
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Maximal anxiety perceived during lumbar puncture evaluated using a simple numeric 0-10 scale [ Time Frame: 2-3 minutes after the end of gas inhalation ]
    Proportion of patients with significant anxiety
  • Side effects [ Time Frame: From the beginning of gas inhalation to a minimum of 2 hours later ]
    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 [ Time Frame: 2-3 minutes after the end of lumbar puncture ]
    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 [ Time Frame: 2-3 minutes after the end of lumbar puncture ]
    Comparison of number of attempts needed to get spinal fluid, defined as number of needle removals for a single exam.
  • Patient Satisfaction [ Time Frame: 2-3 minutes after the end of gas inhalation ]
    overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions
  • Blinding quality [ Time Frame: 2-3 minutes after the end of gas inhalation ]
    Assessment of blinding in clinical trials (according to Bang et al. 2004)
  • Induced cost [ Time Frame: through study completion, an average 4 months ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar Puncture in Emergency Under Nitrous OXide
Official Title  ICMJE Impact of 50% Nitrous Oxide Inhalation on Pain Induced by Lumbar Puncture in Emergency: a Double-blind Randomized Controlled Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2).
Masking: Triple (Participant, Care Provider, Outcomes 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
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Anxiety
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: Nitrous oxyde
    will inhale experimental treatment throughout the entire procedure (50% N2O - 50% 02)
    Intervention: Drug: Fixed 50:50 mixture of nitrous oxide and oxygen
  • Placebo Comparator: Placebo
    will inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.)
    Intervention: Other: Placebo
Publications *
  • 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.
  • Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019) 		88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941990
Other Study ID Numbers  ICMJE RBHP 2018 MOISSET
2018-001296-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE
  • Inserm U1107, NeuroDol
  • Université d'Auvergne
Investigators  ICMJE Not Provided
PRS Account University Hospital, Clermont-Ferrand
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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