Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02533908
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2015-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-21'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2015-07-20', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score', 'timeFrame': 'up to 18 months', 'description': 'the Patient is videotaped during the painful procedure and afterwards the video is analysed using the FLACC score. Each category is scored on a 0-2 scale (5 categories) which results in a total score of 0 (no pain) -10 (severe pain).'}], 'secondaryOutcomes': [{'measure': 'adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal', 'timeFrame': 'up to 18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Inhalation of Nitrous Oxide', 'Opioid Analgesic Adverse Reaction', 'Pain']}, 'referencesModule': {'references': [{'pmid': '30630844', 'type': 'DERIVED', 'citation': 'Seiler M, Staubli G, Landolt MA. Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial. Emerg Med J. 2019 Mar;36(3):142-147. doi: 10.1136/emermed-2018-207892. Epub 2019 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.', 'detailedDescription': "Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. At the emergency department of the Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not significant better than N20 70% combined with basic analgetics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for nitrous oxide 70% application\n* boys/girls aged 2-16 years\n* informed consent\n\nExclusion Criteria:\n\n* due to language barrier no sufficient communication possible to explain the study\n* incompatibility to Fentanyl Sintetica\n* incompatibility to morphinomimetics'}, 'identificationModule': {'nctId': 'NCT02533908', 'briefTitle': 'Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children: A Prospective, Randomized, Double-blind, Placebo-controlled, Monocentric Study', 'orgStudyIdInfo': {'id': 'Fentanyl-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl intranasal', 'description': 'Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once', 'interventionNames': ['Drug: Fentanyl intranasal']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl 0.9% intranasal', 'description': 'NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg', 'interventionNames': ['Drug: NaCl 0.9% intranasal']}], 'interventions': [{'name': 'Fentanyl intranasal', 'type': 'DRUG', 'otherNames': ['Fentanyl Sintetica'], 'description': 'fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation', 'armGroupLabels': ['Fentanyl intranasal']}, {'name': 'NaCl 0.9% intranasal', 'type': 'DRUG', 'otherNames': ['NaCl 0.9% Sintetica'], 'description': 'Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation', 'armGroupLabels': ['NaCl 0.9% intranasal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "Children's Hospital", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Michelle Seiler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital of Zurich"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}