Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03404518
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}], 'ancestors': [{'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khanguyen@llu.edu', 'phone': '909-558-8558', 'title': 'Khanh Nguyen, MD', 'organization': 'Loma Linda University Health System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Some patients chose to not follow study instructions strictly and utilized ibuprofen therapy as primary analgesic treatment instead of their opioid medication.'}}, 'adverseEventsModule': {'timeFrame': 'Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery', 'description': 'Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Norco and Ibuprofen', 'description': 'This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.\n\nNorco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 4, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibuprofen and Norco', 'description': 'This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.\n\nIbuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 3, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'notes': 'Patient reported headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drainage from surgical site', 'notes': 'Patient had additional blood tinged secretion from surgical site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uncontrolled pain', 'notes': 'Patient requiring additional pain medication refill', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Patient reported nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Narcotic Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Norco and Ibuprofen', 'description': 'This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.\n\nNorco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control'}, {'id': 'OG001', 'title': 'Ibuprofen and Norco', 'description': 'This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.\n\nIbuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '6.3'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '3.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 7 days after surgery', 'description': 'The average number of narcotic pills needed or used for pain control', 'unitOfMeasure': 'Pills', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Norco and Ibuprofen', 'description': 'This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.\n\nNorco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control'}, {'id': 'OG001', 'title': 'Ibuprofen and Norco', 'description': 'This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.\n\nIbuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.1'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average reported pain for first 7 days after surgery', 'description': 'The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ibuprofen Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Norco and Ibuprofen', 'description': 'This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.\n\nNorco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control'}, {'id': 'OG001', 'title': 'Ibuprofen and Norco', 'description': 'This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.\n\nIbuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '5.7'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '9.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 7 days after surgery', 'description': 'The average number of ibuprofen pills needed or used for pain control', 'unitOfMeasure': 'pills', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Norco and Ibuprofen', 'description': 'This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.\n\nNorco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control'}, {'id': 'FG001', 'title': 'Ibuprofen and Norco', 'description': 'This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.\n\nIbuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Norco and Ibuprofen', 'description': 'This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.\n\nNorco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control'}, {'id': 'BG001', 'title': 'Ibuprofen and Norco', 'description': 'This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.\n\nIbuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'spread': '17', 'groupId': 'BG000'}, {'value': '52.9', 'spread': '17', 'groupId': 'BG001'}, {'value': '53', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Prior Narcotic use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgery Length', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '94.4', 'spread': '43', 'groupId': 'BG000'}, {'value': '95.3', 'spread': '43', 'groupId': 'BG001'}, {'value': '94.8', 'spread': '42.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Revision Surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients who completed and returned pain data entry'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-16', 'size': 253390, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-08T13:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2018-01-11', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2018-01-11', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-18', 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Narcotic Usage', 'timeFrame': 'First 7 days after surgery', 'description': 'The average number of narcotic pills needed or used for pain control'}], 'secondaryOutcomes': [{'measure': 'Patient Pain Level', 'timeFrame': 'Average reported pain for first 7 days after surgery', 'description': 'The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.'}, {'measure': 'Ibuprofen Usage', 'timeFrame': 'First 7 days after surgery', 'description': 'The average number of ibuprofen pills needed or used for pain control'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroidectomy', 'Parotidectomy', 'Tympanoplasty', 'Mastoidectomy', 'Septoplasty', 'Sinus Surgery', 'Postoperative pain', 'Outpatient surgery'], 'conditions': ['Outpatient Surgery', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '19221238', 'type': 'BACKGROUND', 'citation': 'Sommer M, Geurts JW, Stessel B, Kessels AG, Peters ML, Patijn J, van Kleef M, Kremer B, Marcus MA. Prevalence and predictors of postoperative pain after ear, nose, and throat surgery. Arch Otolaryngol Head Neck Surg. 2009 Feb;135(2):124-30. doi: 10.1001/archoto.2009.3.'}, {'pmid': '17298314', 'type': 'BACKGROUND', 'citation': 'Foghsgaard S, Foghsgaard J, Homoe P. Early post-operative morbidity after superficial parotidectomy: a prospective study concerning pain and resumption of normal activity. Clin Otolaryngol. 2007 Feb;32(1):54-7. doi: 10.1111/j.1365-2273.2007.01315.x.'}, {'pmid': '26422088', 'type': 'BACKGROUND', 'citation': 'Song CM, Ji YB, Bang HS, Kim KR, Kim H, Tae K. Postoperative Pain After Robotic Thyroidectomy by a Gasless Unilateral Axillo-Breast or Axillary Approach. Surg Laparosc Endosc Percutan Tech. 2015 Dec;25(6):478-82. doi: 10.1097/SLE.0000000000000204.'}, {'pmid': '24735082', 'type': 'BACKGROUND', 'citation': "van Dijk JF, Kappen TH, Schuurmans MJ, van Wijck AJ. The Relation Between Patients' NRS Pain Scores and Their Desire for Additional Opioids after Surgery. Pain Pract. 2015 Sep;15(7):604-9. doi: 10.1111/papr.12217. Epub 2014 Apr 16."}, {'pmid': '21840522', 'type': 'BACKGROUND', 'citation': 'van Dijk JF, van Wijck AJ, Kappen TH, Peelen LM, Kalkman CJ, Schuurmans MJ. Postoperative pain assessment based on numeric ratings is not the same for patients and professionals: a cross-sectional study. Int J Nurs Stud. 2012 Jan;49(1):65-71. doi: 10.1016/j.ijnurstu.2011.07.009. Epub 2011 Aug 15.'}, {'pmid': '21724620', 'type': 'BACKGROUND', 'citation': 'Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.'}, {'pmid': '24521559', 'type': 'BACKGROUND', 'citation': 'Ossiander EM. Using textual cause-of-death data to study drug poisoning deaths. Am J Epidemiol. 2014 Apr 1;179(7):884-94. doi: 10.1093/aje/kwt333. Epub 2014 Feb 11.'}], 'seeAlsoLinks': [{'url': 'https://www.cdc.gov/mmwr/volumes/65/wr/mm655051e1.htm', 'label': 'CDC report on opioid related deaths'}]}, 'descriptionModule': {'briefSummary': "Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.", 'detailedDescription': "It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.\n\nThe objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.\n\nPatients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing one of the following outpatient procedure:\n\n* Septoplasty\n* Unilateral or Bilateral Functional endoscopic sinus surgery\n* Tympanomastoidectomy\n* Tympanoplasty\n* Total or Partial Thyroidectomy\n* Parathyroidectomy\n* Parotidectomy.\n* Age \\>18 years and \\< 89 years\n\nExclusion Criteria:\n\n* Age \\< 18 years or \\> 89 years\n* Post operative hospital admission\n* Allergy to Hydrocodone\n* Allergy or contraindication to Ibuprofen or NSAIDs\n* Pregnancy\n* Hepatic disease\n* Chronic kidney disease\n* Sickle cell anemia'}, 'identificationModule': {'nctId': 'NCT03404518', 'briefTitle': 'Patient Narcotic Requirements After Outpatient Otolaryngology Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Quantifying Narcotic Use in Outpatient Otolaryngology Procedures', 'orgStudyIdInfo': {'id': '5170252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norco and Ibuprofen', 'description': 'This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.', 'interventionNames': ['Drug: Norco']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen and Norco', 'description': 'This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.\n\nIf pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.', 'interventionNames': ['Drug: Ibuprofen']}], 'interventions': [{'name': 'Norco', 'type': 'DRUG', 'otherNames': ['Hydrocodone/Acetaminophen', 'Narcotic'], 'description': 'Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control', 'armGroupLabels': ['Norco and Ibuprofen']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['NSAID', 'Motrin', 'Advil'], 'description': 'Ibuprofen as first line therapy every 6 hours as needed for pain control', 'armGroupLabels': ['Ibuprofen and Norco']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Surgical Hospital', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Jared Inman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Collected data will be analyzed and published. Meaningful data will be available through published material.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jared Inman', 'investigatorAffiliation': 'Loma Linda University'}}}}