Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05435118
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2022-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'collaboration', 'timeFrame': '30 minutes', 'description': 'children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)'}], 'secondaryOutcomes': [{'measure': 'pain perception in 2 years-old children', 'timeFrame': '30 minutes', 'description': 'pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997)'}, {'measure': 'pain perception in 3 to 5 years-old children', 'timeFrame': '30 minutes', 'description': 'pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988)'}, {'measure': 'side effect 1', 'timeFrame': '30 minutes', 'description': 'vomiting during procedure Due to not available scales, numerical values from 0 (absence of sign) to 3 (presence of sign requiring medical intervention ) will be assigned to these signs'}, {'measure': 'side effect 2', 'timeFrame': '30 minutes', 'description': 'gag reflex during procedure Due to not available scales, numerical values from 0 (absence of sign) to 3 (presence of sign requiring medical intervention ) will be assigned to these signs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Acute', 'Child, Only', "Nurse's Role", 'Nitrous Oxide']}, 'referencesModule': {'references': [{'pmid': '40762409', 'type': 'DERIVED', 'citation': 'Maiandi S, Coluccia S, Ghizzardi G, Nicardi R, Giacchero R, Lusignani M, Gianni ML, Edefonti VC. Effectiveness of Equimolar Mixture of Oxygen and Nitrous Oxide Combined With Audiovisual in Young Children: A Randomised Controlled Trial. Eur J Pain. 2025 Sep;29(8):e70096. doi: 10.1002/ejp.70096.'}, {'pmid': '37419632', 'type': 'DERIVED', 'citation': 'Maiandi S, Ghizzardi G, Edefonti V, Giacchero R, Lusignani M, Gianni ML. Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy. BMJ Open. 2023 Jul 7;13(7):e067912. doi: 10.1136/bmjopen-2022-067912.'}]}, 'descriptionModule': {'briefSummary': "Children experience numerous painful experiences from nursing procedures: peripheral venous access placement is the main cause of procedural pain.\n\nAs much as pharmacological and nonpharmacological tools are known, their application during venipuncture is not systematic by children's hospitals.\n\nAmong pharmacological tools, the Equimolar Mixture of Nitrogen Protoxide and Oxygen (EMONO) provides adequate protection from procedural pain through inhalation of the gas mixture at least 3 minutes before the procedure.\n\nLiterature reports that the combination of nonpharmacological distractive tools and pharmacological interventions increases their analgesic effect.\n\nThe aim of the study is to measure children's cooperation during procedure (primary outcome), pain perception and side effects when EMONO is combined with audiovisuals compared with EMONO alone in peripheral venous access placement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 2 years and 5 years and 364 days\n* Prescription for peripheral venous access placement\n* Parental consent for participation in the study\n* Presence of at least one parent in possession of a smartphone/tablet with the ability to connect to the Internet through Wi-Fi available to users\n* Absence of contraindications to the administration of EMONO reported in health records\n* Absence of facial pathology\n* Presence on duty of at least one experimental nurse trained in the use of EMONO\n\nExclusion Criteria:\n\n* Age less than 2 years and more than 5 years and 364 days\n* No parental consent to participate in the study\n* Parents not in possession of a smartphone/tablet with the ability to connect to the internet through Wi-Fi available to users\n* Presence of contraindications to EMONO administration\n* Presence of facial pathology\n* Oxygen therapy\n* Presence of tracheostomy\n* Absence on duty of at least one experimental nurse trained in the use of EMONO'}, 'identificationModule': {'nctId': 'NCT05435118', 'acronym': 'EMONO', 'briefTitle': 'Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale di Lodi'}, 'officialTitle': 'Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals During Peripheral Venous Access Insertion of Children Between 2-5 Years Old Children', 'orgStudyIdInfo': {'id': 'INF202201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'EMONO (usual care administered to all the children undergoing painful procedures)', 'description': 'Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask. In the hospital EMONO is administered to all the children for procedure pain control.'}, {'type': 'EXPERIMENTAL', 'label': 'EMONO + audiovisuals tool', 'description': 'Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask and vision of audiovisual toll with smartphone or tablet. The intervention is represented by the audiovisual tool.', 'interventionNames': ['Other: EMONO + audiovisuals tool']}], 'interventions': [{'name': 'EMONO + audiovisuals tool', 'type': 'OTHER', 'description': 'EMONO + use of audiovisuals tool on smartphone or tablet', 'armGroupLabels': ['EMONO + audiovisuals tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26900', 'city': 'Lodi', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Stefano Maiandi', 'geoPoint': {'lat': 45.30989, 'lon': 9.50085}}], 'overallOfficials': [{'name': 'Stefano Maiandi, PhDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Socio Sanitaria Territoriale di Lodi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale di Lodi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc PhDs - Health Professionals Directorate', 'investigatorFullName': 'Stefano Maiandi', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale di Lodi'}}}}