Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-27 @ 2:36 PM
Study NCT ID:
NCT03031795
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2016-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Ketorolac for Pain Relief During IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D020911', 'term': 'Ketorolac Tromethamine'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.elliott@ohiohealth.com', 'phone': '614-566-3643', 'title': 'John O. Elliott PhD, MPH Research Specialist Medical Education', 'organization': 'OhioHealth'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '45 minutes prior and up to 10 minutes post IUD placement', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement\n\nKetorolac: Oral Tablet', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'look alike placebo\n\nPlacebos', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Before, During and After IUD Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac', 'description': 'Experimental group'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo group'}], 'classes': [{'title': 'Pain expected during the procedure', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Pre-procedure pain rating', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Tenaculum placement', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Uterine sounding', 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Deployment of the IUD', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Overall pain rating during the procedure', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Level of pain 10 minutes post procedure', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was set at \\< 0.05 for each row comparison with no adjustment for multiple comparisons.', 'groupDescription': 'A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from "very severe" (8) to "severe pain" (6) or from "moderate pain" (4) to "mild pain" (2).', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Before, during and after IUD placement', 'description': 'Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement\n\nKetorolac: Oral Tablet'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'look alike placebo\n\nPlacebos'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketorolac', 'description': 'Experimental group'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Control group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2016-11-30', 'resultsFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-28', 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Before, During and After IUD Placement', 'timeFrame': 'Before, during and after IUD placement', 'description': 'Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intrauterine device'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after surgical procedures. When taken orally, it should not cause sedation. The purpose of this study is to determine if oral ketorolac is effective at reducing pain during IUD placement versus a placebo tablet.', 'detailedDescription': 'In the United States, 10% of women choose an intrauterine device (IUD) for contraception. With typical use, unintended pregnancy rates in the first year of IUD contraception are 0.8% (Copper T) and 0.2% (LNG). It is known that long-acting, reversible contraception methods reduce the long-term cost of unintended pregnancies. A common deterrent to intrauterine contraception is the fear of pain during placement. Methods of pain relief during IUD insertion must be fast-acting but have minimal sedation. There have been many attempts to find effective pain relief during IUD placement. Neither ibuprofen nor naproxen have been shown to be effective in reducing pain. Misoprostol has been used to increase cervical ripening; however, pain was not decreased, and side effects of nausea and vomiting were increased. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reversibly inhibiting cyclooxygenase-1 and 2.Time to peak plasma concentration ketorolac in the oral form is 44 minutes. Studies have shown that one dose of ketorolac can be as potent as morphine. Ketorolac is also well established for pain control in the immediate post-operative period. A recent study showed that intramuscular ketorolac wais effective in reducing pain after IUD insertion, but 20% of the participants reported that after the procedure, the injection site was as painful as the IUD placement. The current study was designed to evaluate if there is reduced pain during IUD placement using oral ketorolac 40-60 minutes before the procedure compared to a placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-pregnant\n* English speaking women\n* 18 years of age or older desiring an IUD for contraception\n\nExclusion Criteria:\n\n* enrollment in another study\n* pre-medication with any type of analgesic medication\n* contraindication to an IUD\n* weight under 50 kg\n* allergy to non-steroidal anti-inflammatory medications\n* past medical history of liver disease, renal disease, peptic ulcer disease or recent gastrointestinal bleed,\n* daily narcotic pain use\n* positive cultures for gonorrhea or chlamydia.'}, 'identificationModule': {'nctId': 'NCT03031795', 'briefTitle': 'Oral Ketorolac for Pain Relief During IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'OhioHealth'}, 'officialTitle': 'Oral Ketorolac for Pain Relief During IUD Insertion: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OH1-13-00503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement', 'interventionNames': ['Drug: Ketorolac']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'look alike placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': 'Oral Tablet', 'armGroupLabels': ['experimental']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michelle Crawford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OhioHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will share our published manuscript upon request:\n\nCrawford M, Davy S, Book N, Elliott JO, Arora A. Oral ketorolac for pain relief during intrauterine device insertion: a double-blinded randomized controlled trial. Journal of Obstetrics and Gynaecology Canada 2017, Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OhioHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}