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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 September 2015 |
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Main ID: |
NCT02243826 |
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Date of registration:
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16/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial
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Scientific title:
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Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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66 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02243826 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre CLAVELOU |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients coming in the neurology department for a scheduled lumbar puncture
- 18 to 60 years.
- no previous use of nitrous oxide
Exclusion Criteria:
- contra-indication to nitrous oxide use
- Body Mass Index>35
- Mini Mental State Examination <26/30
- Temperature >38°C
- Confusion
- Patient unable to communicate verbaly
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lumbar Puncture
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Intervention(s)
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Drug: 50:50 mixture of nitrous oxide/oxygen
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Primary Outcome(s)
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Maximal pain level during the procedure
[Time Frame: at day 1]
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Secondary Outcome(s)
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Proportion of patients that would accept another lumbar puncture in the same conditions
[Time Frame: at day 1]
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Total duration of the lumbar puncture
[Time Frame: at day 1]
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Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)
[Time Frame: at day 1]
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Proportion of patients presenting side effects
[Time Frame: at day 1]
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Maximal anxiety level during the procedure
[Time Frame: at day 1]
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Secondary ID(s)
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2014-001452-28
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CHU-206
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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