Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT06389318
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002697', 'term': 'Chloral Hydrate'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Both participant and the care-provider in this trial were blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ramsay sedation score', 'timeFrame': 'RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing', 'description': 'The scoring criteria were as follows: (1) patient shows anxiety and restlessness; (2) patient is cooperative, oriented, and quiet; (3) patient is responsive to instructions; (4) patient shows somnolence and responsive to the tapping of the glabella or to loud auditory stimuli; (5) patient shows somnolence and unresponsive to the tapping of the glabella or to loud auditory stimuli; and (6) patient shows somnolence without any response.'}], 'secondaryOutcomes': [{'measure': 'Parental separation anxiety scale', 'timeFrame': 'Preoperatively', 'description': 'Parental separation anxiety scale was determined when the child was separated from the parents according to four levels:\n\n1. easy to separate\n2. sobbing but easy to cease\n3. crying loudly and difficult to stop but without holding the parents and not letting them go\n4. crying loudly and holding the parents and not willing to let them go. PSAS scores of 1 and 2 were considered "successful separation from parents'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midazolam', 'Dexmedetomidine', 'Chloral Hydrate'], 'conditions': ['Inguinal Hernia Repair']}, 'descriptionModule': {'briefSummary': 'Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients', 'detailedDescription': "Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients.\n\nThe administration of sedatives to a child before entering a surgical room is the most common way of reducing the child's distress and allows the child to undergo smooth anesthesia induction.\n\nChloral hydrate is a widely used sedative for young children undergoing imaging studies, with a high success rate.\n\nDexmedetomidine is a highly selective alpha-2 agonist for paediatric sedation. It produces sedation like natural non-rapid eye movement sleep and has respiratory-sparing effect."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 2 to 7\n* American Society of Anaesthesiology (ASA) І and П scheduled for inguinal hernia repair\n\nExclusion Criteria:\n\n* sensitivity to dexmedetomidine or midazolam,\n* infection of the upper respiratory tract,\n* severe liver or kidney disease, organ dysfunction,\n* cardiac arrhythmia or congenital heart disease'}, 'identificationModule': {'nctId': 'NCT06389318', 'briefTitle': 'Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Comparison Between Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Reducing Parental Separation Anxiety in Children Undergoing Inguinal Hernia Repair: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RC 29-11-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'buccal midazolam group', 'description': 'Children received oral placebo syrup, intranasal 0.9 % normal saline at 0.03 ml/kg and buccal midazolam at 0.1 mg/ kg mixed with simple syrup', 'interventionNames': ['Drug: buccal midazolam +oral placebo syrup']}, {'type': 'EXPERIMENTAL', 'label': 'oral chloral hydrate and intranasal dexmedetomidine group', 'description': 'Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline.', 'interventionNames': ['Drug: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline']}], 'interventions': [{'name': 'buccal midazolam +oral placebo syrup', 'type': 'DRUG', 'otherNames': ['Group A'], 'description': 'Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 μg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe.', 'armGroupLabels': ['buccal midazolam group']}, {'name': 'oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline', 'type': 'DRUG', 'otherNames': ['Group B'], 'description': 'Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 μg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe.', 'armGroupLabels': ['oral chloral hydrate and intranasal dexmedetomidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'country': 'Egypt', 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Ramy Saleh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be available upon reasonable request from the principle investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt', 'investigatorFullName': 'Ramy Mousa', 'investigatorAffiliation': 'Benha University'}}}}