Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-01 @ 6:17 PM
Study NCT ID:
NCT04769557
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2021-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2021-02-06', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative pain', 'timeFrame': 'during luxation of tooth', 'description': 'A 10 mm Visual Analogue Scale with higher score depicting severe pain'}, {'measure': 'postoperative pain', 'timeFrame': '1 day', 'description': 'A 10 mm Visual analogue scale with higher score depicting severe pain'}], 'secondaryOutcomes': [{'measure': 'Time to rescue medication', 'timeFrame': 'upto 360 minutes', 'description': 'minutes'}, {'measure': 'number of patients taking rescue medications', 'timeFrame': 'Upto 360 minutes', 'description': 'Total number of patients taking rescue medications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy of pre-emptive paracetamol in reducing intra operative pressure and post operative pain after surgical removal of impacted mandibular third molar using visual analogue scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 21 years and above\n* Healthy patients (ASA I)\n* Patients who are not allergic to the drugs and local anesthetic agents used\n\nExclusion Criteria:\n\n* Patients who are on concurrent treatment with NSAIDs or corticosteroids\n* Patients with pericoronitis or periapical infection'}, 'identificationModule': {'nctId': 'NCT04769557', 'briefTitle': 'Pre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Melaka Manipal Medical College'}, 'officialTitle': 'Pre-emptive Analgesics for Additional Pain Relief in Impacted Third Molar Surgery by depositing4% Articaine With 1:200000 Epinephrine Using Vazirani-Akinosi Closed Mouth Technique- A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MMMC/FOD/AR/B5/E C-2017(07)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paracetamol', 'description': 'Paracetamol', 'interventionNames': ['Drug: paracetamol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'paracetamol', 'type': 'DRUG', 'otherNames': ['Paracetamol 500 mg'], 'description': 'tablet paracetamol 500 mg', 'armGroupLabels': ['Paracetamol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71510', 'city': 'Malacca', 'country': 'Malaysia', 'facility': 'Melaka manipal medical college', 'geoPoint': {'lat': 2.196, 'lon': 102.2405}}], 'overallOfficials': [{'name': 'Abdul K azad, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melaka Manipal Medical College'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melaka Manipal Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Abdul Kalam Azad', 'investigatorAffiliation': 'Melaka Manipal Medical College'}}}}