Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT02359305
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2014-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011707', 'term': 'Pyloric Stenosis'}], 'ancestors': [{'id': 'D017219', 'term': 'Gastric Outlet Obstruction'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Arlyne.Thung@nationwidechildrens.org', 'phone': '614-722-4200', 'title': 'Dr. Arlyne Thung', 'organization': "Nationwide Children's Hospital - Dept. of Anesthesiology & Pain Medicine"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During hospital stay following surgery (average 1-3 days).', 'eventGroups': [{'id': 'EG000', 'title': 'IV Acetaminophen', 'description': 'Acetaminophen administered by intravenous infusion.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rectal Acetaminophen', 'description': 'Acetaminophen administered by rectal suppository.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acetaminophen Dosage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Acetaminophen administered by intravenous infusion.'}, {'id': 'OG001', 'title': 'Rectal Acetaminophen', 'description': 'Acetaminophen administered by rectal suppository.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '30.7', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'One time in the OR prior to the start of surgery', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Average FLACC Pain Score in the PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Acetaminophen administered by intravenous infusion.'}, {'id': 'OG001', 'title': 'Rectal Acetaminophen', 'description': 'Acetaminophen administered by rectal suppository.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-60 minutes post-operatively', 'description': 'The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.', 'unitOfMeasure': 'units on a scale 0-10', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PACU Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Acetaminophen', 'description': 'Acetaminophen administered by intravenous infusion.'}, {'id': 'OG001', 'title': 'Rectal Acetaminophen', 'description': 'Acetaminophen administered by rectal suppository.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '50.4', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '45-60 minutes post-operatively', 'description': 'Time spent in the post-anesthesia care unit post-operatively.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Acetaminophen', 'description': 'Acetaminophen given by intravenous infusion.'}, {'id': 'FG001', 'title': 'Rectal Acetaminophen', 'description': 'Acetaminophen given by rectal suppository.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Acetaminophen', 'description': 'Acetaminophen administered by intravenous infusion.'}, {'id': 'BG001', 'title': 'Rectal Acetaminophen', 'description': 'Acetaminophen administered by rectal suppository.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '16.5', 'groupId': 'BG001'}, {'value': '36', 'spread': '15.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2014-07-31', 'resultsFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-18', 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acetaminophen Dosage', 'timeFrame': 'Baseline', 'description': 'One time in the OR prior to the start of surgery'}, {'measure': 'Average FLACC Pain Score in the PACU', 'timeFrame': '0-60 minutes post-operatively', 'description': 'The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.'}], 'secondaryOutcomes': [{'measure': 'PACU Time', 'timeFrame': '45-60 minutes post-operatively', 'description': 'Time spent in the post-anesthesia care unit post-operatively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pyloric Stenosis']}, 'descriptionModule': {'briefSummary': 'This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who presented for pyloromyotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who presented for pyloromyotomy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02359305', 'briefTitle': 'Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB14-00149'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IV Acetaminophen', 'description': 'Acetaminophen administered by intravenous infusion.', 'interventionNames': ['Drug: Acetaminophen']}, {'label': 'Rectal Acetaminophen', 'description': 'Acetaminophen administered by rectal suppository.', 'interventionNames': ['Drug: Acetaminophen']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Ofirmev'], 'description': 'Acetaminophen given by IV', 'armGroupLabels': ['IV Acetaminophen']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Acephen, Feverall'], 'description': 'Acetaminophen suppository given rectally', 'armGroupLabels': ['Rectal Acetaminophen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arlyne Thung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Arlyne Thung', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}