Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-03-13 @ 11:55 AM
Study NCT ID:
NCT03228628
Status:
UNKNOWN
Last Update Posted:
2017-07-25
First Post:
2017-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrous Oxide for Lumbar Puncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-21', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with significant pain', 'timeFrame': '2-3 minutes after the end of gaz inhalation', 'description': 'maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with significant anxiety', 'timeFrame': '2-3 minutes after the end of gaz inhalation', 'description': 'maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale'}, {'measure': 'Analgesic efficacy measured with pain as a continuous variable', 'timeFrame': '2-3 minutes after the end of gaz inhalation.', 'description': 'maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale'}, {'measure': 'Anxiolytic efficacy measured with anxiety as a continuous variable', 'timeFrame': '2-3 minutes after the end of gaz inhalation', 'description': 'maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale'}, {'measure': 'Pain during the procedure evaluated one hour after the end of the lumbar puncture', 'timeFrame': '1 hour after the end of gaz inhalation', 'description': 'maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale'}, {'measure': 'Anxiety during the procedure evaluated one hour after the end of the lumbar puncture', 'timeFrame': '1 hour after the end of gaz inhalation', 'description': 'maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale'}, {'measure': 'Side effects', 'timeFrame': 'from the beginning of gaz inhalation to 24 hours later', 'description': 'every side effects reported by the patients during the procedure up to 24 hours after the lumbar puncture, including post-puncture puncture headache'}, {'measure': 'Impact of age on side effects', 'timeFrame': 'during the procedure and the 24 hours after', 'description': 'incidence and type of side effects according to patient age'}, {'measure': 'Induced cost', 'timeFrame': 'at day 1', 'description': 'supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal puncture', 'Pain', 'Anxiety', 'Nitrous oxyde'], 'conditions': ['Pain', 'Anxiety']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.\n\nPatients 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).\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients coming in the neurology department for a lumbar puncture\n* at least 18\n* no previous use of nitrous oxide\n\nExclusion Criteria:\n\n* contra-indication to nitrous oxide use\n* Body Mass Index\\>35\n* Mini Mental State Examination \\<24/30\n* Temperature \\>38°C\n* Confusion\n* Patient unable to communicate verbaly'}, 'identificationModule': {'nctId': 'NCT03228628', 'acronym': 'NO for LP', 'briefTitle': 'Nitrous Oxide for Lumbar Puncture', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CHU-342'}, 'secondaryIdInfos': [{'id': '2017-002750-37', 'type': 'OTHER', 'domain': '2017-002750-37'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous oxide', 'description': 'will inhale experimental treatment (50% N2O - 50% O2)', 'interventionNames': ['Drug: Fixed 50:50 mixture of nitrous oxide and oxygen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'will inhale medical air (22% O2 - 78% N2)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Fixed 50:50 mixture of nitrous oxide and oxygen', 'type': 'DRUG', 'description': 'Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.', 'armGroupLabels': ['Nitrous oxide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'inhale medical air (22% O2 - 78% N2)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Xavier MOISSET, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sandra VUKUSIC, MD-PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bruno BROCHET, MD-PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre CLAVELOU, MD-PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Xavier MOISSET, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Clermont-Ferrand, Inserm, Neuro-Dol'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': "Université d'Auvergne", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}