Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
Study NCT ID:
NCT06662968
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2024-10-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-26', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative agitation score', 'timeFrame': 'Time Frame: intraoperative period,10 minutes-1 hours', 'description': 'Postoperative agitation score will be recorded at 6 time points, including the time of entering the recovery room (Time 0), when the lollipop is given (Time 1), when the lollipop is given for 10 minutes(Time 2), when the lollipop is given for 20 minutes(Time 3), when the lollipop is given for 30 minutes(Time 4) and leave the recovery room (T5).'}, {'measure': 'Incidence of nausea and vomiting', 'timeFrame': 'Postoperative 1 minute-5hours', 'description': 'Incidence of nausea and vomiting will be recorded during the time of the recovery room and four hours after returning to the ward .'}], 'secondaryOutcomes': [{'measure': 'Spo2', 'timeFrame': 'Postoperative 1 minute - 5hours', 'description': 'Spo2 will be continuous monitoring and recorded during the time of the recovery room'}, {'measure': 'other adverse reactions', 'timeFrame': 'Postoperative 10 minutes - 3days', 'description': 'The occurrence of adverse reactions( wound infection and others) were continuous monitoring and recorded after the operation'}, {'measure': 'the time of leaving the recovery room and the hospital', 'timeFrame': 'Postoperative 1 hour - 3days', 'description': 'the time of leaving the recovery room and the hospital will be recorded'}, {'measure': 'family satisfaction', 'timeFrame': 'Postoperative 5 hours', 'description': 'Record the satisfaction of the parents with this operation ,defined as a score out of 100'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lollipops', 'Adenotonsillectomy'], 'conditions': ['Adenotonsillectomy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to observe the consumption effect of early lollipop sucking in preschool children after adenotonsillectomy through clinical experiments, and to explore the impact of early postoperative lollipop consumption on postoperative agitation, incidence of postoperative nausea and vomiting, and postoperative wound recovery rate.\n\nParticipants will be randomly allocated to two groups:a lollipop sucking group (Group A) and a control group (Group B), Two groups of children were sent to the recovery room (PACU) for observation after extubation . Group A patients were given lollipops for sucking after waking up, while Group B received routine nursing treatment.\n\nThe goal of this clinical trial is to explore whether lollipops have advantages in early postoperative feeding and alleviating postoperative agitation in children, and to provide reliable clinical evidence for the consumption of lollipops after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who choose to have adenotonsillectomy surgery\n* the American Society of Anesthesiologists (ASA) physical status ranked I-II\n* competent to provide informed consent\n\nExclusion Criteria:\n\n* psychiatric disorders\n* upper respiratory tract infection\n* high risk of reflux aspiration\n* carbohydrate malabsorption syndrome and other endocrine or genetic metabolic diseases (contraindications of lollipop ingredients)'}, 'identificationModule': {'nctId': 'NCT06662968', 'briefTitle': 'A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Maternal and Child Health Hospital of Hubei Province'}, 'officialTitle': 'A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy:a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MCHH_006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lollipop group', 'description': 'Lollipop group patients were given lollipops for sucking in the PACU'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control group patients were received routine nursing treatment in the PACU.'}], 'interventions': [{'name': 'Lollipop group', 'type': 'OTHER', 'description': 'In the Lollipop group,children were sent to the recovery room (PACU) for observation after extubation after surgery.They were given lollipops for sucking without chewing after waking up.Throughout the entire sucking process, we continuously monitor vital signs.'}, {'name': 'Control group', 'type': 'OTHER', 'description': 'In the Control group,children were sent to the recovery room (PACU) for observation after extubation after surgery.They were received routine nursing treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Maternal and Child Health Hospital of Hubei Province', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Na Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maternal and Child Health Hospital of Hubei Province'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maternal and Child Health Hospital of Hubei Province', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Li Na', 'investigatorAffiliation': 'Maternal and Child Health Hospital of Hubei Province'}}}}