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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Lumbar Puncture in Emergency Under Nitrous OXide

Clinicaltrials.gov identifier NCT03941990

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted February 20, 2020

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:Pain
    Anxiety
  • Intervention/Treatment: Drug: Fixed 50:50 mixture of nitrous oxide and oxygen
    Other: Placebo
  • Phase: 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
  • Study Type: Interventional
  • 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)
  • 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 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
  • 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

Contact: Lise LACLAUTRE, Dr (0)473754963 promo_interne_drci@chu-clermontferrand.fr

Locations

France, Auvergne Rhône-Alpes
CHU de Clermont-Ferrand
Clermont-Ferrand

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Inserm U1107, NeuroDol

Université Clermont-Auvergne

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