Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06423820
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2024-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': '24 hours postoperatively', 'description': 'The incidence of postoperative nausea and vomiting (PONV) will be measured in the first 24 postoperative hours at the intervals of 0-2h (early PONV), 2-12h (delayed PONV), and 12- 24h (late PONV)'}], 'secondaryOutcomes': [{'measure': 'Severity of postoperative nausea and vomiting (PONV)', 'timeFrame': '24 hours postoperatively', 'description': 'The severity of postoperative nausea and vomiting (PONV) will be scored as follows: \\[0 = no nausea and no retching; 1 complaining of sickness and retching; vomiting one or two times in 30 min; and 3 vomiting more than two times in 30 min\\] in the first 24 hours postoperatively.'}, {'measure': 'Number of emetic episodes', 'timeFrame': '24 hours postoperatively', 'description': 'Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively.'}, {'measure': 'Time to onset of emesis', 'timeFrame': '24 hours postoperatively', 'description': 'Time to onset of emesis will be measured from the end of surgery till 24 hours postoperatively.'}, {'measure': 'Incidence of oculo-cardiac reflex (OCR)', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of oculo-cardiac reflex (OCR) will be recorded. OCR is defined as a 10-20% decrease in the resting heart rate and/or the occurrence of any arrhythmia.'}, {'measure': 'Parental satisfaction', 'timeFrame': '24 hours postoperatively', 'description': 'Degree of parental satisfaction by using an 11-pointverbal numeric scoring system (0 = not at all satisfied, 10 = fully satisfied).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ondansetron Lozenge', 'Postoperative Nausea and Vomiting', 'Pediatrics', 'Squint']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.', 'detailedDescription': 'Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.\n\nIn several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.\n\nOndansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 4 to 15 years.\n* American Society of Anesthesiology (ASA) physical status I, II.\n* Pediatric patients undergoing squint surgeries.\n\nExclusion Criteria:\n\n* Patients who had received any medication with antiemetic properties within 24 h before surgery.\n* Post-operative period (for reasons other than rescue antiemetic therapy).\n* Patients with known liver or renal disease.\n* Patients with a history of vomiting or retching within 24 h before surgery.'}, 'identificationModule': {'nctId': 'NCT06423820', 'briefTitle': 'Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR640/4/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group S (Ondansetron lozenge)', 'description': 'Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group.', 'interventionNames': ['Drug: Ondansetron lozenge']}, {'type': 'NO_INTERVENTION', 'label': 'Group C (Control)', 'description': 'Pediatric patients will not receive ondansetron as a control group.'}], 'interventions': [{'name': 'Ondansetron lozenge', 'type': 'DRUG', 'description': 'Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.', 'armGroupLabels': ['Group S (Ondansetron lozenge)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohammed Said ElSharkawy', 'investigatorAffiliation': 'Tanta University'}}}}