PainPhase 4NO for LPNCT03228628
Nitrous Oxide for Lumbar Puncture
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.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 162 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2017to 1 Sep 2019
- 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
- Patients coming in the neurology department for a lumbar puncture
- at least 18
- no previous use of nitrous oxide
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Xavier MOISSET, MD-PhD
About this study
Official title: Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial
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.
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 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.
- Being tested
- Fixed 50:50 mixture of nitrous oxide and oxygen, Placebo
- Keywords
- Spinal puncture, Pain, Anxiety, Nitrous oxyde
- Medical subject headings
- Pain, Anxiety Disorders
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 group | Role | What they receive |
|---|---|---|
| Nitrous oxide | Experimental | will inhale experimental treatment (50% N2O - 50% O2) Receives: Drug: Fixed 50:50 mixture of nitrous oxide and oxygen |
| Placebo | Placebo comparator | will inhale medical air (22% O2 - 78% N2) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with significant pain
maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
Measured: 2-3 minutes after the end of gaz inhalation
Secondary outcomes (8)
Proportion of patients with significant anxiety
maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
Measured: 2-3 minutes after the end of gaz inhalation
Analgesic efficacy measured with pain as a continuous variable
maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
Measured: 2-3 minutes after the end of gaz inhalation.
Anxiolytic efficacy measured with anxiety as a continuous variable
maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
Measured: 2-3 minutes after the end of gaz inhalation
Pain during the procedure evaluated one hour after the end of the lumbar puncture
maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
Measured: 1 hour after the end of gaz inhalation
Anxiety during the procedure evaluated one hour after the end of the lumbar puncture
maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
Measured: 1 hour after the end of gaz inhalation
Side effects
every side effects reported by the patients during the procedure up to 24 hours after the lumbar puncture, including post-puncture puncture headache
Measured: from the beginning of gaz inhalation to 24 hours later
Impact of age on side effects
incidence and type of side effects according to patient age
Measured: during the procedure and the 24 hours after
Induced cost
supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Oct 2017 (estimated)
- Primary completion6 Jun 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Hospices Civils de Lyon, Institut National de la Santé Et de la Recherche Médicale, France, Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Xavier MOISSET, MD-PhD, Principal investigator, CHU Clermont-Ferrand, Inserm, Neuro-Dol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228628
- Sponsor's protocol ID
- CHU-342
- Other IDs
- 2017-002750-37, 2017
- Acronym
- NO for LP
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03228628
- Acronym / sponsor ID
- NO for LP / CHU-342
- Keywords
- Spinal puncture, Pain, Anxiety, Nitrous oxyde
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Hospices Civils de Lyon, Institut National de la Santé Et de la Recherche Médicale, France, Université d'Auvergne
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 6 Jun 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)
| Arm | Type | Receives |
|---|---|---|
| Nitrous oxide | Experimental | Drug: Fixed 50:50 mixture of nitrous oxide and oxygenwill inhale experimental treatment (50% N2O - 50% O2) |
| Placebo | Placebo comparator | Other: Placebowill inhale medical air (22% O2 - 78% N2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients coming in the neurology department for a lumbar puncture
- at least 18
- no previous use of nitrous oxide
Key exclusion criteria (6 listed)
- contra-indication to nitrous oxide use
- Body Mass Index>35
- Mini Mental State Examination <24/30
- Temperature >38°C
- Confusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed 50:50 mixture of nitrous oxide and oxygenGaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure. | Drug | Nitrous oxide |
| Placeboinhale medical air (22% O2 - 78% N2) | Other | Placebo |
Primary outcome
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
8 secondary outcomes
Proportion of patients with significant anxiety
Time frame: 2-3 minutes after the end of gaz inhalation
Analgesic efficacy measured with pain as a continuous variable
Time frame: 2-3 minutes after the end of gaz inhalation.
Anxiolytic efficacy measured with anxiety as a continuous variable
Time frame: 2-3 minutes after the end of gaz inhalation
Pain during the procedure evaluated one hour after the end of the lumbar puncture
Time frame: 1 hour after the end of gaz inhalation
Anxiety during the procedure evaluated one hour after the end of the lumbar puncture
Time frame: 1 hour after the end of gaz inhalation
Side effects
Time frame: from the beginning of gaz inhalation to 24 hours later
Impact of age on side effects
Time frame: during the procedure and the 24 hours after
Induced cost
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier MOISSET, MD-PhD principal investigator
CHU Clermont-Ferrand, Inserm, Neuro-Dol
1 site in 1 country: see every site and its status.
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 3 inclusion and 6 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 25 Jul 2017. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with significant pain (time frame: 2-3 minutes after the end of gaz inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2017.