Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-23 @ 11:42 PM
Study NCT ID:
NCT02387918
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of POV After Paediatric Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009325', 'term': 'Nausea'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2015-03-09', 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of POV after tonsillectomy with or without adenoidectomy', 'timeFrame': '24 hours postoperatively', 'description': 'by 3 point ordinal scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tonsillectomy', 'postoperative vomiting (POV)', 'Dexamethasone', 'Acupuncture'], 'conditions': ['Vomiting']}, 'descriptionModule': {'briefSummary': 'Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.', 'detailedDescription': 'Postoperative vomiting (POV) is one of the most common complication in children undergoing tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given. Because of Limited efficacy and side effects with antiemetics, many alternative treatment had been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The objective of this study is to compare two prophylactic antiemetic treatments :\n\n* Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia\n* Acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 2-8 y.\n* children ASA 1-2\n* tonsillectomy with or without adenoidectomy\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)\n* intravenous induction\n* contraindication to steroids\n* Rash or local infection over an acupuncture point\n* administration of steroids in the 24 hours before the surgery\n* Use of medication with antiemetic effect within the 24 hours before surgery\n* Gastric or intestinal diseases\n* refusal of parents'}, 'identificationModule': {'nctId': 'NCT02387918', 'briefTitle': 'Prevention of POV After Paediatric Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture', 'orgStudyIdInfo': {'id': 'SM2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture', 'description': 'Acupuncture at point Neiguan (Pericardium-6) bilaterally and at point CV13 (Shang Wen) with acupuncture needles (0.25x25 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed after 20 minutes', 'interventionNames': ['Device: Acupuncture']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Acupuncture', 'type': 'DEVICE', 'description': 'Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)', 'armGroupLabels': ['Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Egypt', 'state': 'Assuit', 'country': 'Egypt', 'facility': 'Faculty of Medicine Assuit University'}], 'overallOfficials': [{'name': 'Seham Ibrahim, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'health,Higher education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Seham Mohamed Moeen Ibrahim', 'investigatorAffiliation': 'Assiut University'}}}}