Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-04-24 @ 4:53 AM
Study NCT ID:
NCT02665533
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D014313', 'term': 'Trismus'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'D003061', 'term': 'Codeine'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-surgical swelling of third molar extraction determined using linear measures in the face', 'timeFrame': 'Up to seven days post-surgical', 'description': 'During the post-surgical intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face.'}, {'measure': 'Post-surgical trismus of third molar extraction determined by maximum mouth opening', 'timeFrame': 'Up to seven days post-surgical', 'description': 'During the post-surgical intervals of 24, 48 and 72 hours and seven days, the trismus was determined by maximum mouth opening.'}, {'measure': 'Post-surgical pain of third molar extraction using visual analogic scale', 'timeFrame': 'Up to seven days post-surgical', 'description': 'The post-surgical pain was self-recorded by the patient using visual analogic scale in intervals of 24, 48 and 72 hours and seven days.'}], 'secondaryOutcomes': [{'measure': 'Analgesic consumption', 'timeFrame': 'Up to seven days post-surgical'}, {'measure': 'Duration of surgery', 'timeFrame': 'Up to seven days post-surgical'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain measurement', 'edema', 'trismus'], 'conditions': ['Pain', 'Edema', 'Trismus']}, 'descriptionModule': {'briefSummary': 'The main aim of the study is to investigate the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.', 'detailedDescription': 'The surgery of third molar is usually associated with important post-surgical sequelae. The damage caused to tissue and bone may result in considerable pain, edema and trismus. The symptoms start gradually, peaking in 2 days after the extraction. The use of medications such as dexamethasone and diclofenac associated to codeine may support the prevention of post-surgical pain. This clinical trial aim compare the the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with indication of asymptomatic bilateral extractions of lower third molars;\n* Aged 18 years or older;\n* Have a good health and no disease;\n\nExclusion Criteria:\n\n* Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT02665533', 'briefTitle': 'Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of the Valleys of Jequitinhonha and Mucuri'}, 'officialTitle': 'Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery', 'orgStudyIdInfo': {'id': '1.354.720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Dexamethasone 8 mg, one capsule single preoperative dose.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Diclofenac Sodium associated with Codeine', 'description': 'Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.', 'interventionNames': ['Drug: Diclofenac Sodium associated with Codeine']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexamethasone Acetate'], 'description': 'Dexamethasone 8 mg', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Diclofenac Sodium associated with Codeine', 'type': 'DRUG', 'description': 'Diclofenac Sodium 50 mg associated with Codeine 50 mg', 'armGroupLabels': ['Diclofenac Sodium associated with Codeine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100000', 'city': 'Diamantina', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri', 'geoPoint': {'lat': -18.24692, 'lon': -43.60345}}], 'overallOfficials': [{'name': 'Thiago Lima', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of the Valleys of Jequitinhonha and Mucuri'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of the Valleys of Jequitinhonha and Mucuri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}