Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT06489327
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-06-22', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preoperative anxiety', 'timeFrame': '24 hours', 'description': 'The child\'s anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as "calm," while the other end shows "maximum anxiety." The patients were asked to assess their own anxiety and mark it on the anxiety line.'}], 'secondaryOutcomes': [{'measure': 'preoperative sedation', 'timeFrame': '24 hours', 'description': "The sedation level will be assessed using Ramsay Sedation Scale. It divides a patient's level of sedation into six categories ranging from severe agitation at 1 to deep coma at 6."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative anxiety', 'general anesthesia', 'major surgery', 'oral melatonin', 'placebo', 'premedication'], 'conditions': ['Preoperative Anxiety']}, 'descriptionModule': {'briefSummary': 'Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.\n\nIn order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.\n\nMelatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either sex\n* age from 4 to 14 years\n* Patients with American society Anesthesiologist physical status I and II\n* Patients undergoing elective surgeries\n\nExclusion Criteria:\n\n* ASA more than III\n* Drug allergy.\n* Gastrointestinal disorders.'}, 'identificationModule': {'nctId': 'NCT06489327', 'briefTitle': 'Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial', 'orgStudyIdInfo': {'id': '042/2021/Babel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1st group: melatonin 0.2 mg/kg group', 'description': 'patients will receive oral melatonin at a dose of 0.2 mg/kg', 'interventionNames': ['Drug: melatonin (Circadin ®) 0.2 mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2nd group: M04 groupmelatonin 0.4 mg/kg group', 'description': 'patients will receive oral melatonin at a dose of 0.4 mg/kg', 'interventionNames': ['Drug: melatonin (Circadin ®) 0.4 mg/kg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3rd group: placebo group', 'description': 'patients will receive oral placebo premedication', 'interventionNames': ['Drug: placebo group']}], 'interventions': [{'name': 'melatonin (Circadin ®) 0.2 mg/kg', 'type': 'DRUG', 'description': 'Patients will receive oral melatonin at a dose of 0.2 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.', 'armGroupLabels': ['1st group: melatonin 0.2 mg/kg group']}, {'name': 'melatonin (Circadin ®) 0.4 mg/kg', 'type': 'DRUG', 'description': 'Patients will receive oral melatonin at a dose of 0.4 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.', 'armGroupLabels': ['2nd group: M04 groupmelatonin 0.4 mg/kg group']}, {'name': 'placebo group', 'type': 'DRUG', 'description': 'Patients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.', 'armGroupLabels': ['3rd group: placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11765', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Neveen Kohaf', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '01060383012'}, {'name': 'Haider Hamza, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Facualty of Pharmacy, Al Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '51015', 'city': 'Madīnat Bābil', 'state': 'Babel', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'Haider Hamza, M.D', 'role': 'CONTACT', 'email': 'hussein.hussein@alayen.edu.iq', 'phone': '+9647811593388'}], 'facility': 'Al-Ayen Univerisity', 'geoPoint': {'lat': 32.53991, 'lon': 44.41477}}], 'centralContacts': [{'name': 'Neveen Kohaf, Ph.D', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '01060383012'}], 'overallOfficials': [{'name': 'Neveen Kohaf, ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'data will be shared upon resealable request from the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Ayen Iraqi University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Neveen Abd El Maksoad Kohaf', 'investigatorAffiliation': 'Al-Azhar University'}}}}