Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT00337792
Status:
TERMINATED
Last Update Posted:
2016-03-18
First Post:
2006-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'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'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'whyStopped': 'DSMB review at 50% recruitment, further recruitment unlikely to change result', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2006-06-15', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scale'}], 'secondaryOutcomes': [{'measure': 'Measures of satisfaction, side effects, recovery time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Undesired Pregnancy']}, 'referencesModule': {'references': [{'pmid': '19155895', 'type': 'DERIVED', 'citation': 'Allen RH, Fitzmaurice G, Lifford KL, Lasic M, Goldberg AB. Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):276-83. doi: 10.1097/AOG.0b013e3181938758.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.', 'detailedDescription': 'The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older.\n* Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.\n* Has already signed consent for pregnancy termination.\n* Eligible for IV sedation per clinic protocol.\n\nExclusion Criteria:\n\n* Under 120 lbs.\n* Allergies to any of the drugs being studied.\n* Chronic narcotics, barbiturates or benzodiazepine use within the past year.\n* History of IV drug use within the last year.\n* Inability to give informed consent.\n* Does not speak English or Spanish and does not have translator for all study procedures\n* Previously participated in study'}, 'identificationModule': {'nctId': 'NCT00337792', 'briefTitle': 'Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)', 'organization': {'class': 'OTHER', 'fullName': 'Planned Parenthood League of Massachusetts'}, 'officialTitle': 'A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion', 'orgStudyIdInfo': {'id': '2005-P-002284/1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'oxycodone + lorazepam versus fentanyl + midazolam', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Planned Parenthood League of Massachusetts', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jane Doe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Planned Parenthood League of Massachusetts'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Planned Parenthood League of Massachusetts', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jane Doe', 'oldOrganization': 'Planned Parenthood League of MA'}}}}