Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT07172594
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Oral Lactium to Prevent Emergence Agitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of emergence agitation', 'timeFrame': 'Up to 1 hour after surgery.', 'description': 'Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour'}], 'secondaryOutcomes': [{'measure': 'Parental separation anxiety', 'timeFrame': 'Perioperative', 'description': "It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 will be considered as 'acceptable' separation"}, {'measure': 'Mask Acceptance Score', 'timeFrame': 'Perioperative', 'description': "Ease of mask acceptance will be graded using the Mask Acceptance Score. It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A score of 1 or 2 will be considered 'satisfactory' mask acceptance"}, {'measure': 'Postoperative pain', 'timeFrame': 'Up to 1 hour after surgery.', 'description': 'the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at PACU arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl.'}, {'measure': 'Total dose of rescue fentanyl', 'timeFrame': 'Up to 1 hour after surgery.', 'description': 'Fentanyl will be given for agitation or pain'}, {'measure': 'Pediatric Anesthesia Emergence Delirium scale scores', 'timeFrame': 'Up to 1 hour after surgery.', 'description': 'severity of agitation will be assessed by Pediatric Anesthesia Emergence Delirium scale.'}, {'measure': 'Number of patients who will develop postoperative nausea and vomiting.', 'timeFrame': 'Up to 2 hours after surgery.', 'description': 'Any episodes of nausea and vomiting will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lactium', 'Emergence Agitation', 'Adenotonsillectomy']}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled study will be conducted to evaluate the effects of preoperative lactium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.', 'detailedDescription': 'Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. Lactium is a synthetic derivative of alpha-s1 casein hydrolysate (ACH) containing the alpha-casozepine peptide, which is one of the main components of milk protein. It contains benzodiazepine-like α-casozepine, which has been shown to interact with gamma-aminobutyric acid receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive administration of Lactium may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation , the efficacy of Lactium in alleviating stress-related symptoms, that may be obtained before anesthetic induction may explain its prophylactic benefit against emergence agitation .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both gender\n* 4 to 7 years age\n* American Society of Anesthesiologists (ASA) Physical Status I or II\n* Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia\n\nExclusion Criteria:\n\n* Parents declined to participate in the trial\n* Children with behavioral changes; neurological or psychiatric diseases\n* Physical or developmental delay\n* Sedative or anticonvulsant medication\n* Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders\n* • History of lactose intolerance'}, 'identificationModule': {'nctId': 'NCT07172594', 'briefTitle': 'Preemptive Oral Lactium to Prevent Emergence Agitation', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Preemptive Oral Lactium Supplement to Prevent Emergence Agitation in Children Undergoing Adenotonsillectomy: A Randomized Placebo Controlled Study', 'orgStudyIdInfo': {'id': '36264PR1306/7/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactium group', 'description': 'cases will receive preoperative lactium, Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery.', 'interventionNames': ['Drug: Lactium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'cases will receive 50 ml water added to it powdered vanilla flavor, 2 hours before surgery.', 'interventionNames': ['Other: Placebo control']}], 'interventions': [{'name': 'Lactium', 'type': 'DRUG', 'description': 'Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery.', 'armGroupLabels': ['Lactium group']}, {'name': 'Placebo control', 'type': 'OTHER', 'description': '50 ml water added to it powdered vanilla flavor will be given to cases 2 hours before surgery.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Radwa E Eissa, MD', 'role': 'CONTACT', 'email': 'radwa.emad@med.tanta.edu.eg', 'phone': '+201007473944', 'phoneExt': '002'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Radwa E Eissa, MD', 'role': 'CONTACT', 'email': 'radwa.emad@med.tanta.edu.eg', 'phone': '01007473944', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesiology, surgical intensive care and pain medicine', 'investigatorFullName': 'Radwa Emad Eissa', 'investigatorAffiliation': 'Tanta University'}}}}