Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-05 @ 6:22 PM
Study NCT ID:
NCT03074968
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2017-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001591', 'term': 'Benzydamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2017-02-26', 'studyFirstSubmitQcDate': '2017-03-04', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '30 minutes in postanesthetic care unit', 'description': 'application based pain score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '32247315', 'type': 'DERIVED', 'citation': 'Yhim HB, Yoon SH, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 4;20(1):77. doi: 10.1186/s12871-020-00995-y.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to examine the effect of benzydamine hydrochloride to postoperative sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative sore throat using smartphone application in pediatric patients.', 'detailedDescription': '1. postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe\n2. scoring of pain with smartphone application (kids pain scale)\n3. incidence of use of rescue pain killer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* general anesthesia\n* intubation require\n\nExclusion Criteria:\n\n* recent upper airway infection\n* could not express the pain'}, 'identificationModule': {'nctId': 'NCT03074968', 'briefTitle': 'Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H1612-061-813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'normal saline', 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'benzydamine hydrochloride', 'description': 'Benzydamine Hydrochloride', 'interventionNames': ['Drug: Benzydamine Hydrochloride']}], 'interventions': [{'name': 'Benzydamine Hydrochloride', 'type': 'DRUG', 'otherNames': ['difflam'], 'description': 'Benzydamine Hydrochloride application', 'armGroupLabels': ['benzydamine hydrochloride']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['ns'], 'description': 'normal saline application', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15710', 'city': 'Seoul', 'state': 'Jongro Gu', 'country': 'South Korea', 'facility': 'SNUH', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hee-Soo Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hee-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}