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Nitrous Oxide for Lumbar Puncture (NO for LP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228628
Recruitment Status : Unknown
Verified July 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
University Hospital, Bordeaux
Hospices Civils de Lyon
Inserm U1107, NeuroDol
Université d'Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot single-center study, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this multi-center trial is to confirm these results in a larger and more heterogeneous group of patients having a LP.

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 single-centre study.

Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.

Patients with scheduled 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 of time. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 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: Double (Participant, Outcomes Assessor)
Masking Description: double blinding. Gaz bottles are in undistinguishable boxes. Neither the patients nor the person doing the LP and the evaluation of pain and anxiety will know the treatment used
Primary Purpose: Treatment
Official Title: Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : June 6, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Nitrous oxide
will inhale experimental treatment (50% N2O - 50% O2)
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 (22% O2 - 78% N2)
Other: Placebo
inhale medical air (22% O2 - 78% N2)




Primary Outcome Measures :
  1. Proportion of patients with significant pain [ Time Frame: 2-3 minutes after the end of gaz inhalation ]
    maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale


Secondary Outcome Measures :
  1. Proportion of patients with significant anxiety [ Time Frame: 2-3 minutes after the end of gaz inhalation ]
    maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale

  2. Analgesic efficacy measured with pain as a continuous variable [ Time Frame: 2-3 minutes after the end of gaz inhalation. ]
    maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale

  3. Anxiolytic efficacy measured with anxiety as a continuous variable [ Time Frame: 2-3 minutes after the end of gaz inhalation ]
    maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale

  4. Pain during the procedure evaluated one hour after the end of the lumbar puncture [ Time Frame: 1 hour after the end of gaz inhalation ]
    maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale

  5. Anxiety during the procedure evaluated one hour after the end of the lumbar puncture [ Time Frame: 1 hour after the end of gaz inhalation ]
    maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale

  6. Side effects [ Time Frame: from the beginning of gaz inhalation to 24 hours later ]
    every side effects reported by the patients during the procedure up to 24 hours after the lumbar puncture, including post-puncture puncture headache

  7. Impact of age on side effects [ Time Frame: during the procedure and the 24 hours after ]
    incidence and type of side effects according to patient age

  8. Induced cost [ Time Frame: at day 1 ]
    supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients coming in the neurology department for a lumbar puncture
  • at least 18
  • no previous use of nitrous oxide

Exclusion Criteria:

  • contra-indication to nitrous oxide use
  • Body Mass Index>35
  • Mini Mental State Examination <24/30
  • Temperature >38°C
  • Confusion
  • Patient unable to communicate verbaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228628


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Xavier MOISSET, MD-PhD         
Sub-Investigator: Sandra VUKUSIC, MD-PhD         
Sub-Investigator: Bruno BROCHET, MD-PhD         
Sub-Investigator: Pierre CLAVELOU, MD-PhD         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Hospital, Bordeaux
Hospices Civils de Lyon
Inserm U1107, NeuroDol
Université d'Auvergne
Investigators
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Principal Investigator: Xavier MOISSET, MD-PhD CHU Clermont-Ferrand, Inserm, Neuro-Dol
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03228628    
Other Study ID Numbers: CHU-342
2017-002750-37 ( Other Identifier: 2017-002750-37 )
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Spinal puncture
Pain
Anxiety
Nitrous oxyde
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents