Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 6:43 PM
Study NCT ID:
NCT05508451
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2022-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2022-08-13', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination on the postoperative 30th minute, first hour and 2th hour VAS (Visual Analog Scale) of double-jaw surgery patients.', 'timeFrame': 'at the first hour', 'description': 'VAS ( Pain intensity was assessed on a 100-mm Visual Analog Scale (VAS), where 0 = no pain and 100 = worst possible pain'}, {'measure': 'The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination', 'timeFrame': 'at the second hour', 'description': 'VAS ( Pain intensity was assessed on a 100-mm Visual Analog Scale (VAS), where 0 = no pain and 100 = worst possible pain'}, {'measure': 'The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination', 'timeFrame': 'at the 24th hour', 'description': 'VAS ( Pain intensity was assessed on a 100-mm Visual Analog Scale (VAS), where 0 = no pain and 100 = worst possible pain'}], 'secondaryOutcomes': [{'measure': 'The secondary efficacy variable was the number of opioid and rescue drug consumptions during the postoperative 24 hours.', 'timeFrame': 'during the postoperative 24 hours.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam'], 'conditions': ['Postoperative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Postoperative pain is generally caused by inflammation and oedema related to tissue trauma. Surgical tissue trauma is caused by many factors such as cotery-related burns, surgical incisions, dissections, and instrumental procedures like cutting, stretching, or compression.\n\nThe pain stimulus is triggered by mediators released by the traumatic tissue and transmitted to the spinal cord and then to the upper centres of the brain. Tenoxicam is an analgesic, anti-inflammatory, and antipyretic drug with a long duration of action, included in the oxicam subgroup of NSAIDs. Tenoxicam has been studied and found effective for many rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, gout, extra-articular disorders, bursitis, tendonitis, and osteoarthritis. The primary aim of this study was to compare the effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination analgesic applications on the postoperative VAS score of double-jaw surgery patients. The secondary aim was to investigate the effects of these interventions on the number of both opioid and rescue analgesic drug consumption postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '18-50', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18-50 aged of both genders who were scheduled for elective bimaxillary surgery\n* Classified as American Society of Anesthesiologists (ASA) risk class I or II\n\nExclusion Criteria:\n\n* having liver or renal dysfunction\n* coagulopathy disorder,\n* having psychiatric or medical conditions that might impair communication or compliance with the study procedures\n* having allergy or contra-indications to the study drugs .pregnancy.\n* patients who were planned to undergo additional simultaneous surgical procedures such as genioplasty were not included in the study. -'}, 'identificationModule': {'nctId': 'NCT05508451', 'briefTitle': 'Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Comparison of the Efficacy of Tenoxicam, Paracetamol (Acetaminophen), and Tenoxicam-Paracetamol Combination on Postoperative Pain in Double-Jaw Surgery Patients', 'orgStudyIdInfo': {'id': '2018/303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'paracetamol', 'interventionNames': ['Procedure: Double jaw surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tenoxicam', 'interventionNames': ['Procedure: Double jaw surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tenoxicam+paracetamol', 'interventionNames': ['Procedure: Double jaw surgery']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Procedure: Double jaw surgery']}], 'interventions': [{'name': 'Double jaw surgery', 'type': 'PROCEDURE', 'description': 'A type of orthognathic surgery', 'armGroupLabels': ['paracetamol', 'placebo', 'tenoxicam', 'tenoxicam+paracetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Seher Orbay Yaşlı', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'seher Orbay Yaşlı', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erciyes University Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Anesthesiologist', 'investigatorFullName': 'seher orbay yasli', 'investigatorAffiliation': 'TC Erciyes University'}}}}