Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 2:45 PM
Study NCT ID:
NCT04669457
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-25
First Post:
2020-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The surgeon and post-operative nurses will be masked to the group allocation. Masking will only be revealed if medically necessary.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to onset of pediatric delirium', 'timeFrame': 'Zero minutes to 48 hours', 'description': 'Time from when the patient is woken from anesthesia to the onset of delirium.'}, {'measure': 'Time to offset of pediatric delirium', 'timeFrame': 'Zero minutes to 48 hours', 'description': 'Time from onset of delirium to the offset of delirium.'}, {'measure': 'Duration of pediatric delirium', 'timeFrame': 'Zero minutes to 48 hours', 'description': 'Total time patient experiences delirium'}], 'secondaryOutcomes': [{'measure': 'Drug Acceptance', 'timeFrame': '10-25 minutes prior to surgery', 'description': 'The willingness of the subject to take the drug was assessed in the pre-operative area'}, {'measure': 'Parental Separation Anxiety Scale (PSAS)', 'timeFrame': '0-48 hours', 'description': 'Anxiety score was determined when the child was separated from the parents according to four levels.'}, {'measure': 'Mask Acceptance Scale', 'timeFrame': '1-10 minutes prior to surgery', 'description': "The child's acceptance of the mask by the anesthesiologist was rated as follows."}, {'measure': 'End tidal Sevoflurane value', 'timeFrame': '0-12 hours', 'description': 'During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented.'}, {'measure': 'Rescue analgesia in PACU', 'timeFrame': '0-6 hours post surgery', 'description': 'The amount and dose of oral/rectal acetaminophen given in PACU was recorded.'}, {'measure': 'Home Behavior Analysis', 'timeFrame': '12-48 hours', 'description': "The child's parents were given a diary to document their behavior for 48 hours post-operatively at home."}, {'measure': 'Oral analgesic use', 'timeFrame': 'Two days post-operative', 'description': 'Document intake of oral analgesics like acetaminophen or ibuprofen'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Delirium']}, 'descriptionModule': {'briefSummary': 'Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.', 'detailedDescription': "Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects age 3 months to 9 years\n* Scheduled to undergo a myringotomy\n* American Society of Anesthesiologists (ASA) classification of I - II.\n\nExclusion Criteria:\n\n* Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.\n* Anyone age 10 years or older.\n* Anyone with an ASA classification of III or higher.\n* Non-English language speaker for whom short form consent is not available.'}, 'identificationModule': {'nctId': 'NCT04669457', 'briefTitle': 'Pediatric Delirium', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.', 'orgStudyIdInfo': {'id': 'H00021788'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-nasal Dexmedetomidine', 'description': 'Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.', 'interventionNames': ['Drug: Intra-nasal Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Midazolam', 'description': 'Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.', 'interventionNames': ['Drug: Oral Midazolam']}], 'interventions': [{'name': 'Intra-nasal Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.', 'armGroupLabels': ['Intra-nasal Dexmedetomidine']}, {'name': 'Oral Midazolam', 'type': 'DRUG', 'otherNames': ['Midazolam'], 'description': 'Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.', 'armGroupLabels': ['Oral Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'R. Ian Richmond, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts Chan Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared via publication as group data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Director of Clinical Operations, Dept of Anesthesiology and Perioperative Medicine', 'investigatorFullName': 'R. Ian Richmond', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}