Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-13 @ 9:54 AM
Study NCT ID:
NCT01762306
Status:
UNKNOWN
Last Update Posted:
2013-01-07
First Post:
2012-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Diclofenac on Pain During Endometrial Sampling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-04', 'studyFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2013-01-04', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of Diclofenac Potassium for additional acute pain control in patient undergoing fractional curettage under paracervical block due to abnormal uterine bleeding', 'timeFrame': '1 Year', 'description': 'Effectiveness of oral 50 mg Diclofenac Potassium was measured by pain score using visual dialogue scale during operation and 30, 60, 90 and 120 minutes after procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abnormal Uterine Bleeding Unrelated to Menstrual Cycle']}, 'referencesModule': {'references': [{'pmid': '16047182', 'type': 'BACKGROUND', 'citation': 'Poomtavorn Y, Phupong V. Prospective randomized, double-blinded, placebo-controlled trial of preoperative rofecoxib for pain relief in uterine curettage. Arch Gynecol Obstet. 2005 Dec;273(2):115-8. doi: 10.1007/s00404-005-0041-y. Epub 2005 Jul 27.'}, {'pmid': '18396369', 'type': 'BACKGROUND', 'citation': 'Manyou B, Phupong V. Prospective randomized, double-blinded, placebo-controlled trial of preoperative etoricoxib for pain relief in uterine fractional curettage under paracervical block. Eur J Obstet Gynecol Reprod Biol. 2008 Sep;140(1):90-4. doi: 10.1016/j.ejogrb.2008.02.017. Epub 2008 Apr 8.'}, {'pmid': '16357114', 'type': 'BACKGROUND', 'citation': 'Macintyre PE, Walker S, Power I, Schug SA. Acute pain management: scientific evidence revisited. Br J Anaesth. 2006 Jan;96(1):1-4. doi: 10.1093/bja/aei295. No abstract available.'}, {'pmid': '16241013', 'type': 'BACKGROUND', 'citation': 'Buppasiri P, Tangmanowutikul S, Yoosuk W. Randomized controlled trial of mefenamic acid vs paracervical block for relief of pain for outpatient uterine curettage. J Med Assoc Thai. 2005 Jul;88(7):881-5.'}, {'pmid': '21901726', 'type': 'BACKGROUND', 'citation': 'Moore RA, Derry S, McQuay HJ, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008659. doi: 10.1002/14651858.CD008659.pub2.'}, {'pmid': '19370609', 'type': 'BACKGROUND', 'citation': 'Derry P, Derry S, Moore RA, McQuay HJ. Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004768. doi: 10.1002/14651858.CD004768.pub2.'}, {'pmid': '22619908', 'type': 'BACKGROUND', 'citation': 'Boonyarangkul A, Leksakulchai O. Comparison of level of pain between using manual vacuum aspiration and sharp curettage in management of abnormal uterine bleeding. J Med Assoc Thai. 2011 Dec;94 Suppl 7:S57-61.'}, {'type': 'BACKGROUND', 'citation': 'Hinchy S, Ordman, Burrell A, Vella L, Ward L. Guidelines for the Management of Acute Pain in Adults. NHS trust; 2008.'}]}, 'descriptionModule': {'briefSummary': 'Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number of patients, the diagnosis of its cause is performed via fractional curettage under local anesthesia such as paracervical nerve block or intravenous meperidine.\n\nPain is one of a common adverse effect of this procedure and this topic should be concerned by a responsible doctor.\n\nNSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain control and is as effective as coxib in acute pain management. Because of its cost, easy accessible and easy administration, Diclofenac Potassium was selected to be used in this study. Its onset of action is about 1 hour and only one dose of this drug do not cause any serious side effects.\n\nThe hypothesis of this study is that "Diclofenac Potassium has an additional effectiveness for acute pain control in patients undergoing fractional curettage under paracervical nerve block due to abnormal uterine bleeding" Double blind randomised controlled trial was performed in this study with 45 patients included in each group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thai women at the age over 35 years old\n* Presenting with abnormal uterine bleeding and have a plan of performing fractional curettage\n\nExclusion Criteria:\n\n* uterine anomalies\n* pregnancy\n* Pelvic inflammatory disease\n* Uncontrolled medical conditions\n* Known cases of gynecological diseases such as gynecological malignancy, abnormal pap smear\n* NSAIDs allergy\n* contraindicate to NSAIDs use'}, 'identificationModule': {'nctId': 'NCT01762306', 'briefTitle': 'Efficacy of Diclofenac on Pain During Endometrial Sampling', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding', 'orgStudyIdInfo': {'id': 'SIOGMVA001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Potassium', 'description': 'Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage', 'interventionNames': ['Drug: Diclofenac Potassium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Folic Acid', 'description': 'Folic acid 5 mg PO 1 hour prior to fractional curettage', 'interventionNames': ['Drug: Folic Acid']}], 'interventions': [{'name': 'Diclofenac Potassium', 'type': 'DRUG', 'otherNames': ['Cataflam'], 'armGroupLabels': ['Diclofenac Potassium']}, {'name': 'Folic Acid', 'type': 'DRUG', 'armGroupLabels': ['Folic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Korakot Sirimai, Dr.', 'role': 'CONTACT', 'email': 'ksirimai@hotmail.com', 'phone': '(66)81-6140655'}, {'name': 'Korakot Sirimai, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tripop Lertbunnaphong, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine Siriraj Hospital Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Korakot Sirimai, Dr.', 'role': 'CONTACT', 'email': 'ksirimai@hotmail.com', 'phone': '(66)81-6140655'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}