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PainPhase 4LENOXNCT03941990

Lumbar Puncture in Emergency Under Nitrous OXide

A Phase 4 study testing Fixed 50:50 mixture of nitrous oxide and oxygen in people with Pain and Anxiety, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Anxiety
What is being tested?
Fixed 50:50 mixture of nitrous oxide and oxygen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteFrance
Study dates
27 Nov 2019to Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Lise LACLAUTRE, Dr contact

(0)473754963

promo_interne_drci@chu-clermontferrand.fr

France1 site, 1 recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000

    Lise LACLAUTRE, MD-PhD, promo_interne_drci@chu-clermontferrand.fr

    Xavier MOISSET, MD-PhD

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Pain, Anxiety
Being tested
Fixed 50:50 mixture of nitrous oxide and oxygen, Placebo
Keywords
Spinal puncture, Nitrous oxide, Pain, Anxiety, Emergency
Medical subject headings
Pain, Anxiety Disorders, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fixed 50:50 mixture of nitrous oxide and oxygenDrug

    Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.

  • PlaceboOther

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

Study groups in NCT03941990
Study groupRoleWhat they receive
Nitrous oxydeExperimentalwill inhale experimental treatment throughout the entire procedure (50% N2O - 50% 02)
Receives: Drug: Fixed 50:50 mixture of nitrous oxide and oxygen
PlaceboPlacebo comparatorwill inhale medical air throughout the entire procedure (22% O2 + N2 Q.S.)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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?"

    Measured: 2-3 minutes after the end of gas inhalation

Secondary outcomes (7)

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

    Proportion of patients with significant anxiety

    Measured: 2-3 minutes after the end of gas inhalation

  2. 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

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

  3. Spinal puncture duration

    Comparison of LP duration between both groups measured in minutes (from the beginning of gas inhalation to needle removal).

    Measured: 2-3 minutes after the end of lumbar puncture

  4. 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.

    Measured: 2-3 minutes after the end of lumbar puncture

  5. Patient Satisfaction

    overall satisfaction based on a 0-10 score and proportion of patients that would accept another lumbar puncture in the same conditions

    Measured: 2-3 minutes after the end of gas inhalation

  6. Blinding quality

    Assessment of blinding in clinical trials (according to Bang et al. 2004)

    Measured: 2-3 minutes after the end of gas inhalation

  7. 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)

    Measured: through study completion, an average 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start27 Nov 2019
  3. Primary completionApr 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2).
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941990
Sponsor's protocol ID
RBHP 2018 MOISSET
Other IDs
2018-001296-20, 2018
Acronym
LENOX
Status last verified
May 2019
First submitted
2 May 2019
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 26585197

  • 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.

    PubMed 15020033

  • 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.

    PubMed 10193230

  • 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.

    PubMed 17060584

  • 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.

    PubMed 23474866

  • 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.

    PubMed 27336667

  • 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.

    PubMed 27666149

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fixed 50:50 mixture of nitrous oxide and oxygen in people with Pain and Anxiety, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise LACLAUTRE, Dr ((0)473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941990, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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