Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-03-27 @ 6:11 PM
Study NCT ID:
NCT05728892
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2023-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.
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': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Discharge from postanesthesia care unit (1 hour)', 'description': 'Assesment of pain will be done using Face, Leg, Activity , Crying and Consolability behavioural pain scale (FLACC), Each category is scored on the 0-2 scale, which results in a total score of 0-10.\n\n0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain and 7-10 = Severe discomfort or pain or both.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'To study the role of Preoperative Melatonin adminsteration in pediatric patients undergoing laparoscopic surgeries regarding its analgesic and sedative effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 2 to 10 years.\n* Sex: Both sexes.\n* Patients with ASA classificaion I and II.\n\nExclusion Criteria:\n\n* Declining to give written informed consent.\n* History of allergy to the medications used in the study.\n* psychiatric disorder.\n* ASA classification III-V.\n* Fever ,cough , asthma or upper respiratory tract infection, neuromuscular disorders, spine abnormalities.\n* Anticipated difficult airway .\n* History of malignant hyperthermia'}, 'identificationModule': {'nctId': 'NCT05728892', 'briefTitle': 'Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.', 'orgStudyIdInfo': {'id': 'FAMSU R264/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'patients undergoing abdominal surgery receiving melatonin', 'interventionNames': ['Drug: Melatonin 3 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'control group', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Melatonin 3 MG', 'type': 'DRUG', 'description': 'Preopertive melatonin adminstration oral 0.2 mg /kg 45 min before general anaethesia.', 'armGroupLabels': ['Group A']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo medication will be given to control group', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11213', 'city': 'Cairo', 'state': 'Abbasia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherif Wadei, MD', 'role': 'CONTACT', 'phone': '01156622298'}], 'facility': 'Ain shams university hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed A Tolba, MD', 'role': 'CONTACT', 'email': 'Mohamedtolba@med.asu.edu.eg', 'phone': '01156622298'}, {'name': 'Diaaeldein M Haiba', 'role': 'CONTACT', 'phone': '01006516286'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}