Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 2:08 AM
Study NCT ID:
NCT04259333
Status:
UNKNOWN
Last Update Posted:
2020-08-04
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib vs. Acetaminophen/Codeine/Caffeine for Post-operative Analgesia in Rhinoplasty.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000068579', 'term': 'Celecoxib'}, {'id': 'C526278', 'term': 'acetaminophen, codeine drug combination'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-30', 'size': 219801, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-04T12:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The surgeon (Care provider) performing all of the septorhinoplasty procedures will be blinded as to which pain medication the patients will receive postoperatively.\n\nThe outcomes assessor evaluating the severity of bruising (using postoperative photographs taken on day of cast removal) will be blinded as to which pain medication the patient received'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-02', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Severity', 'timeFrame': 'until the time of cast removal (up to 8 days postoperatively)', 'description': 'Difference in daily mean pain intensity based on Numeric Rating Scale (NRS). The NRS is composed of 0 (no pain at all) to 10 (worst imaginable pain).'}], 'secondaryOutcomes': [{'measure': 'Medication-related side effects', 'timeFrame': 'for side effects experienced up to the day of cast removal (up to 8 days postoperatively)', 'description': 'patient self-reported questionnaire'}, {'measure': 'Complications postoperatively', 'timeFrame': 'for complications experienced up to the day of cast removal (up to 8 days postoperatively)', 'description': 'patient self-reported questionnaire'}, {'measure': 'Bruising', 'timeFrame': 'day 6-8. depending on day of cast removal', 'description': 'blinded outcome assessor will rank bruising severity based on Numeric Rating Scale (NRS), using postoperative photographs taken on day of cast removal. The NRS is composed of 0 (no brusing at all) to 10 (worst imaginable bruising).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid', 'rhinoplasty', 'pain, postoperative', 'celecoxib'], 'conditions': ['Pain, Postoperative', 'Surgery--Complications', 'Opioid Analgesic Adverse Reaction', 'Opioid Use']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to evaluate whether celecoxib (CELEBREX) is equivalent to acetaminophen-codeine-caffeine (TYLENOL# 3) for the management of pain after primary elective open septorhinoplasty with osteotomies.\n\nSecondary objectives include comparison of adverse medication effects and complications (e.g., bleeding events and bruising) that occur postoperatively.\n\nHalf of the study participants will receive celecoxib, and half will receive acetaminophen-codeine-caffeine.\n\nWe hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding, but that participants taking CELEBREX will experience less medication-related side effects and less bruising postoperatively.', 'detailedDescription': 'The recent recognition of the opioid crisis has prompted a nationwide search for alternative postoperative analgesia regimens, especially in the field of plastic and reconstructive surgery where patients exhibit a significant risk of persistent opioid use afterward.\n\nAs such, the contemporary facial plastics literature has noticed a surge in publications that implement various multi-modal analgesia (MMA) regimens to mitigate narcotic use postoperatively, the results of which seem promising.\n\nAmong the opioid-sparing medications utilized in MMA regimens, the selective COX-2 inhibitors (e.g., celecoxib, parecoxib) are of interest given their similar analgesic efficacy and decreased risk profile (less nausea, constipation, and dependence) compared to opioids. Furthermore, selective COX-2 inhibitors avoid adverse gastrointestinal and renal events, as well as the antiplatelet effects associated with conventional NSAIDs (e.g., ibuprofen and naproxen). For these reasons, selective COX-2 inhibitors make for the ideal analgesic to use after facial plastic surgery procedures, where increased bleeding can delay wound healing (e.g., increased bruising and swelling) and cause potentially devastating complications (e.g., hematoma after a facelift, or epistaxis after septorhinoplasty). Nonetheless, studies evaluating the role of selective COX-2 inhibitors as safe and effective alternatives to opioids in plastic surgery are scant.\n\nThe primary aim of this study is to evaluate whether celecoxib is equivalent to a routinely prescribed analgesia, acetaminophen-codeine-caffeine (trade name TYLENOL#3) for the management of pain after primary cosmetic open septorhinoplasty with osteotomies. Secondary objectives include comparison of adverse effects that occur post-operatively, with attention to medication side effects, as well as bleeding events and bruising.\n\nWe hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding or bruising, but that participants taking acetaminophen/codeine will experience more adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients 18-80 years old undergoing elective primary open septorhinoplasty with osteotomies by single surgeon, JA.\n\nExclusion Criteria:\n\n* • Patients who undergo a rhinoplasty requiring a rib, ear, or temporalis fascia graft (confounding variables for the level of pain experienced)\n\n * Patients with a known history of chronic pain disorder, or who have gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that may prevent them from taking NSAIDs such as CELEBREX.\n * Patients with a history of radiation, active head and neck malignancy or other chronic pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in assessing pain.'}, 'identificationModule': {'nctId': 'NCT04259333', 'briefTitle': 'Celecoxib vs. Acetaminophen/Codeine/Caffeine for Post-operative Analgesia in Rhinoplasty.', 'organization': {'class': 'OTHER', 'fullName': 'Humber River Hospital'}, 'officialTitle': 'Celecoxib vs. Acetaminophen-codeine-caffeine for Postoperative Pain in Primary Elective Open Septorhinoplasty With Osteotomies: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '16511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Arm', 'description': 'celecoxib 200 mg tablet by mouth every 12 hours for 7 days postoperatively prn pain', 'interventionNames': ['Drug: Celecoxib 200mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'codeine 30mg-acetaminophen 300mg-caffeine 15 mg tabelt by mouth every 4 hours for 7 days postoperatively prn pain', 'interventionNames': ['Drug: Acetaminophen, Codeine Drug Combination']}], 'interventions': [{'name': 'Celecoxib 200mg', 'type': 'DRUG', 'otherNames': ['celebrex'], 'description': 'Celecoxib tablet', 'armGroupLabels': ['Test Arm']}, {'name': 'Acetaminophen, Codeine Drug Combination', 'type': 'DRUG', 'otherNames': ['tylenol #3'], 'description': 'acetaminophen-codeine-caffeine tablet', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4Y 0A2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Blake Raggio, MD', 'role': 'CONTACT', 'email': 'blakeraggio@gmail.com', 'phone': '5042353994'}], 'facility': 'FACE Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Blake S Raggio, MD', 'role': 'CONTACT', 'email': 'blakeraggio@gmail.com', 'phone': '504-235-3994'}], 'overallOfficials': [{'name': 'Jamil Asaria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto | FACE Cosmetic Surgery Toronto'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be available within 6 months of study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available', 'accessCriteria': 'Data access requests will be reviewed by an external Independent Review Panel. Requests will be required to sign a Data Access Agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Blake Raggio', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Fellow', 'investigatorFullName': 'Blake Raggio', 'investigatorAffiliation': 'Humber River Hospital'}}}}