Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT03883893
Status:
WITHDRAWN
Last Update Posted:
2022-04-05
First Post:
2019-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IV Acetaminophen and Post-Tonsillectomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Clinical research coordinator, parent and participant will be masked until participant is discharged from hospital. OR staff will not be masked.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Mentor for PI left institution. Study was not renewed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain scores', 'timeFrame': 'Every 5 minutes after awake in recovery room for 30 minutes', 'description': 'FLACC (Face, Legs, Activity, Cry, Consolability) behavior scale Each area measured is graded 0 - 2 and then totaled. Total score will range from 0 - 10. A total score of 0 - patient is relaxed and comfortable, 1 - 3 - patient is mildly uncomfortable, 4 - 6 - patient is in moderate pain, 7 - 10 - patient is having severe discomfort/pain'}], 'secondaryOutcomes': [{'measure': 'Quality of emergence from anesthesia', 'timeFrame': 'When first spontaneous eye movement occurs in recovery room', 'description': 'Pediatric Anesthesia Emergence Delirium scale (PAED)\n\nThis scale uses 5 criteria to determine the extent of emergence delirium in children. "The child makes eye contact with the caregiver", "The child\'s actions are purposeful", The child is aware of his/her surroundings", The child is restless" and "The child is inconsolable." Each of these 5 catagories are scored on a 0-4 scale. The higher the total number the greater the extent of the emergence delirium.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tonsillectomy', 'Intravenous Acetaminophen', 'Pediatric'], 'conditions': ['Tonsillectomy', 'Adenoidectomy']}, 'descriptionModule': {'briefSummary': 'This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is age 3 to 10 years (inclusive)\n2. The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)\n3. The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear\n4. The subject is ASA patient classification I-II\n5. The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.\n\nExclusion Criteria:\n\n1. Additional surgical procedures are being performed concurrently;\n2. The subject is ASA classification \\> II;\n3. The subject has pre-existing allergy or known hypersensitivity to acetaminophen;\n4. The subject receives midazolam as a premedication;\n5. The subject has a history of chronic malnutrition;\n6. The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study"}, 'identificationModule': {'nctId': 'NCT03883893', 'briefTitle': 'IV Acetaminophen and Post-Tonsillectomy Pain', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients', 'orgStudyIdInfo': {'id': '2018-0565'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV Tylenol', 'description': 'Participants will receive IV acetaminophen 15mg/kg in the OR.', 'interventionNames': ['Drug: Intravenous acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Participants will receive 0.9% normal saline in the OR. The amount received will be equivalent of what would be given if they were receiving IV acetaminophen.', 'interventionNames': ['Other: Normal saline']}], 'interventions': [{'name': 'Intravenous acetaminophen', 'type': 'DRUG', 'otherNames': ['IV Tylenol'], 'description': 'Intravenous acetaminophen will be given in the OR.', 'armGroupLabels': ['IV Tylenol']}, {'name': 'Normal saline', 'type': 'OTHER', 'description': 'Normal saline will given if randomized to this group.', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Judy Audas, APRN-CRNA,MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}