Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-01 @ 7:11 PM
Study NCT ID:
NCT05124067
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2021-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D035061', 'term': 'Control Groups'}], '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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-03', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total granisetron dose given', 'timeFrame': '24 hours', 'description': 'If vomiting occurred more than twice in 2 minutes will be treated with granisetron (0.1mg/kg and repeated if necessary but not in less than 12 hours).'}, {'measure': 'Number of participants with the following side effects', 'timeFrame': '24 hours', 'description': 'Number of participants that will develop bradycardia, hypotension or high blood glucose'}], 'primaryOutcomes': [{'measure': 'Number of participants who will develop postoperative nausea and vomiting and rate of development', 'timeFrame': '24 hours', 'description': 'Postoperative vomiting will be recorded by a nurse who will be blinded to study conditions. It will be treated if vomiting occurred more than twice in 2 minutes with granisetron (0.1mg/kg and repeated if necessary but not in less than 12 hours).'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hours', 'description': 'Postoperative pain will be assessed at 1st, 2nd, 4th, 8th, 12th, 16th and 24th hrs. Postoperative by using the Pediatric Objective Pain Scale, where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia'}, {'measure': 'Emergence delirium', 'timeFrame': '15 minutes', 'description': 'Emergence delirium using the pediatric anesthesia emergence delirium (PAED) scale at four-time points: T0: after extubation; T1: 5 min after extubation; T2: 10 min after extubation; T3: 15 min extubation.\n\nThe PAED scale contains five items: eye contact, the purposefulness of actions, awareness of surroundings, restlessness and consolability. Each item will be scored into five grades (0-4) according to a degree, giving a maximum total of 20 points. Patients with severe agitation defined as a PAED score ≥ 10 will be treated with intravenous propofol (1 mg/kg)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'nausea and vomiting'], 'conditions': ['Postoperative Nausea and Vomiting', 'Post Operative Pain', 'Emergence Delirium']}, 'descriptionModule': {'briefSummary': 'this study will aim to evaluate the effects of dexmedetomidine, dexamethasone and Ondansetron on the prevention of postoperative nausea and vomiting in children undergoing dental rehabilitation surgery.', 'detailedDescription': 'Postoperative nausea and vomiting (PONV) is one of the most common and unpleasant postoperative complications, which is a major concern in surgical patients. PONV affects about 20-40% of surgical patients, with certain high-risk patients experiencing rates of up to 80%.\n\nIt has a high incidence in children, especially for tonsillectomy and dental surgery. PONV could lead to several adverse consequences, including dehydration, electrolyte imbalance, and wound dehiscence. it has also been reported PONV is associated with delayed hospital discharge, unplanned hospital admission, and increased financial costs required for patient care.\n\nSeveral anti-emetic drugs have been described for the prophylactic control of PONV. Dexamethasone is common practice in surgery, as part of a multimodal pain and antiemetic strategy.\n\nOndansetron is a selective 5-HT3 receptor antagonist that exhibits an anti-emetic action by antagonizing vomiting signals in the afferent pathway from the stomach or small intestine and solitary tract nucleus and is effective at preventing PONV, however, the high cost of this drug has prevented it from being widely used.\n\nDexmedetomidine is a highly selective α2-adrenoreceptor agonist which has been widely used in clinical practice and has been explored extensively in the pediatric population due to its beneficial effects on perioperative morbidities. In the past few years, many studies in paediatrics have been published showing that dexmedetomidine lowered postoperative pain scores and opioid consumption, decreased the incidence of emergence agitation (EA), and improved the quality of recovery in pediatric patients undergoing different surgical procedures. In addition, a small selection of studies reported that dexmedetomidine could lower the incidence of nausea or vomiting after surgery and during the use of patient-controlled analgesia (PCA) in paediatrics. However, the effect of dexmedetomidine on PONV remains poorly understood.\n\nIn this study, investigators will evaluate the effect of dexmedetomidine on preventing postoperative nausea and vomiting in children in comparison with dexamethasone and ondansetron'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients 6-12 years.\n* Pediatric patients (ASA physical status I, II).\n* Scheduled for dental rehabilitation surgery\n\nExclusion Criteria:\n\n* Parental refusal\n* Allergy or contraindication to studied medication or anaesthetic agents.\n* Children with known gastroesophageal reflux disease.\n* Intake of antiemetic medication within 24 hours before surgery.\n* Past history or family history of previous postoperative nausea and vomiting.'}, 'identificationModule': {'nctId': 'NCT05124067', 'briefTitle': 'Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect Of Dexmedetomidine, Dexamethasone And Ondansetron On Postoperative Nausea And Vomiting In Children Undergoing Dental Rehabilitation', 'orgStudyIdInfo': {'id': 'IRC13407/10/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (DEXA)', 'description': 'patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (ONDAN)', 'description': 'patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (DEXMED)', 'description': 'Patients will receive dexmedetomidine (0.3 μg/kg)', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group D (CONTROL)', 'description': 'patients will receive normal saline', 'interventionNames': ['Drug: normal Saline']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexamethasone Group'], 'description': 'patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)', 'armGroupLabels': ['Group A (DEXA)']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Ondansetron Group'], 'description': 'patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)', 'armGroupLabels': ['Group B (ONDAN)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine Group'], 'description': 'Patients will receive dexmedetomidine (0.3 μg/kg)', 'armGroupLabels': ['Group C (DEXMED)']}, {'name': 'normal Saline', 'type': 'DRUG', 'otherNames': ['Control Group'], 'description': 'patients will receive normal saline.', 'armGroupLabels': ['Group D (CONTROL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Sharurah', 'state': 'Najran Region', 'country': 'Saudi Arabia', 'facility': 'Sharurah Armed Forces Hospital', 'geoPoint': {'lat': 17.49083, 'lon': 47.11262}}], 'overallOfficials': [{'name': 'AHMED A SHAMA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE'}, {'name': 'SHERIF K ARAFA, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE'}, {'name': 'AMIR A EL-SAYED, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'LECTURER OF ANESTHESIA AND SURGICAL ICU', 'investigatorFullName': 'AHMED ABDELAZIZ SHAMA', 'investigatorAffiliation': 'Tanta University'}}}}