Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-12 @ 3:14 AM
Study NCT ID:
NCT03296020
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2017-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006722', 'term': 'Honey'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized clinical trials that included 2 armes: the control group and the case group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '7 days', 'description': 'pain intensity by visual analouge scale(VAS), the numbers of painkillers taken daily, the number of times the child awaking at night due to pain'}, {'measure': 'Amount of fluids', 'timeFrame': '7 days', 'description': 'what is the amount of fluids intake daily'}, {'measure': 'The time of commencement of regular oral intake.', 'timeFrame': '7-14 days', 'description': 'How long is take post surgery for the child to return to his regular oral intake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of honey administration on pain following pediatric tonsillectomy or adenotonsilectomy.\n\nThe patients( children 2-18 years old) will divide into two groups by simple randomization method( the control group and the case group).\n\nAfter surgery the case group: would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup+ syrup oxycode( as necessary).\n\nthe control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary).\n\nThe families would ask to follow treatment protocols for 7 days. From the first to the 7th day after the operation , the parents would ask to fill a questionnaire every day for assessment of pain intensity by visual analouge scale(VAS) , the numbers of painkillers taken daily, the number of times the child awaking at night due to pain, the amount of fluids intake daily, the time of commencement of regular oral intake.\n\npatient would follow up 7-14 days after surgery.', 'detailedDescription': 'This study was approved by the regional ethics committe of the Hospital. The participants would be: Children (2-18 years old, male and female), who will have the indication of tonsillectomy and will undergo classic tonsillectomy with or without adenoidectom in otolaryngology departement in HaEmek Hospital and they ate already honey in their lives.\n\nExclusion criteria:\n\n* Allergy to honey\n* Allergy to Acetaminophen\n* Patients with Diabeties mellitus\n* pregnent/breast feeding patients\n* patients with coagulation disorders\n* patients who undrego another operation in addition to tonsillectomy with or without adenoidectomy ( except insertion of ventilation tubes surgery).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children ages 2-18 years old that candidates for Tonsillectomy with or without adenoidectomy surgery, in otolaryngolgy department , HaEmek Hospital, Afula.\n* Parents' signature on informed consent form.\n\nExclusion Criteria:\n\n* Allergy to honey\n* Allergy to Acetaminophen\n* Patients with Diabeties mellitus\n* pregnent/breast feeding patients\n* patients with coagulation disorders\n* patients who undrego another operation in addition to tonsillectomy with or without adenoidectomy ( except insertion of ventilation tubes surgery)."}, 'identificationModule': {'nctId': 'NCT03296020', 'briefTitle': 'The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study', 'orgStudyIdInfo': {'id': '0079-17-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'After the surgery, during the hospitalization ,the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary).\n\nAfter the discharge from the hospital - the patients would take( as is customary in our ENT department): acetaminophen syrup ( as necessary) and other painkillers ( as necessary).\n\nThe families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days.'}, {'type': 'EXPERIMENTAL', 'label': 'case group-"HONEY"', 'description': 'After the surgery, during the hospitalization ,the case group would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup + syrup oxycode( as necessary).\n\nAfter the discharge from the hospital - the patients would take:acetaminophen syrup ( as necessary) and other painkillers+honey twice a day( 5 ml- one tea spoon each time) .\n\nThe families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days.', 'interventionNames': ['Other: HONEY']}], 'interventions': [{'name': 'HONEY', 'type': 'OTHER', 'description': '100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL', 'armGroupLabels': ['case group-"HONEY"']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Tzvi chen, MD', 'role': 'CONTACT', 'email': 'TZVIKACHEN@GMAIL.COM', 'phone': '972546151054'}], 'facility': 'HaEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'centralContacts': [{'name': 'Tzvi Chen, MD', 'role': 'CONTACT', 'email': 'tzvikachen@gmail.com', 'phone': '972-546151054'}], 'overallOfficials': [{'name': 'tzvi chen', 'role': 'STUDY_CHAIR', 'affiliation': 'haemek medical center'}, {'name': 'tzvi chen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'haemek medical center'}, {'name': 'TZVI CHEN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'haemek medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}