Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01947205
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2013-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain and Suction Curettage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'C118296', 'term': 'dexketoprofen trometamol'}, {'id': 'D014619', 'term': 'Vacuum Curettage'}, {'id': 'D000773', 'term': 'Anesthesia, Obstetrical'}, {'id': 'D002355', 'term': 'Carticaine'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], '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'}, {'id': 'D004107', 'term': 'Dilatation and Curettage'}, {'id': 'D003475', 'term': 'Curettage'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2013-09-19', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain reduction', 'timeFrame': 'nine months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Curettage', 'analgesia', 'paracervical block', 'paracetamol', 'lidocaine', 'Dexketoprofen trometamol'], 'conditions': ['Curettage', 'Analgesia', 'Paracervical Block', 'Paracetamol']}, 'referencesModule': {'references': [{'pmid': '24455735', 'type': 'DERIVED', 'citation': 'Acmaz G, Aksoy H, Ozoglu N, Aksoy U, Albayrak E. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, and paracervical block application for pain relief during suction termination of first-trimester pregnancy. Biomed Res Int. 2013;2013:869275. doi: 10.1155/2013/869275. Epub 2013 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy.\n\nExclusion Criteria:\n\nincomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets… etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.'}, 'identificationModule': {'nctId': 'NCT01947205', 'briefTitle': 'Pain and Suction Curettage', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'orgStudyIdInfo': {'id': 'Kayseri ERH'}, 'secondaryIdInfos': [{'id': 'KayseriERH', 'type': 'OTHER', 'domain': 'KayseriERH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'paracetamol', 'description': 'Duration', 'interventionNames': ['Drug: paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'without drug', 'description': 'Control group', 'interventionNames': ['Other: without drug']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexketoprofen trometamol', 'description': 'Study group', 'interventionNames': ['Drug: dexketoprofen trometamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'two puff xylocain administration on cervical surface', 'description': 'Study group', 'interventionNames': ['Drug: suction curettage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'paracervical block with ultracaine', 'description': 'study group', 'interventionNames': ['Drug: suction curettage']}], 'interventions': [{'name': 'paracetamol', 'type': 'DRUG', 'armGroupLabels': ['paracetamol']}, {'name': 'dexketoprofen trometamol', 'type': 'DRUG', 'armGroupLabels': ['dexketoprofen trometamol']}, {'name': 'suction curettage', 'type': 'DRUG', 'otherNames': ['two puff xylocain administration'], 'armGroupLabels': ['two puff xylocain administration on cervical surface']}, {'name': 'suction curettage', 'type': 'DRUG', 'otherNames': ['paracervical block with ultracaine'], 'armGroupLabels': ['paracervical block with ultracaine']}, {'name': 'without drug', 'type': 'OTHER', 'armGroupLabels': ['without drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri Education and Research Hospital of Medicine', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Gökhan Açmaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gökhan Açmaz', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Kayseri Education and Research Hospital', 'investigatorFullName': 'Gökhan Açmaz', 'investigatorAffiliation': 'Kayseri Education and Research Hospital'}}}}