Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-27 @ 7:43 AM
Study NCT ID:
NCT01330459
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hydrocodone For Pain Control in First Trimester Surgical Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'C083640', 'term': 'acetaminophen, hydrocodone drug combination'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D008140', 'term': 'Lorazepam'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edelmana@ohsu.edu', 'phone': '(503) 494-3666', 'title': 'Alison Edelman, MD, Assistant Professor', 'organization': 'Oregon Health and Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.', 'otherNumAtRisk': 61, 'otherNumAffected': 2, 'seriousNumAtRisk': 61, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.', 'otherNumAtRisk': 60, 'otherNumAffected': 1, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Uterine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematometra requiring reaspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Perception of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '63.1', 'spread': '26.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of uterine aspiration (baseline)', 'description': 'To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Perception of Pain During Cervical Dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '43.9', 'spread': '28.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)', 'description': 'Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Pain Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.8', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '67.3', 'spread': '24.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)', 'description': 'Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)', 'description': 'To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Additional Intraoperative and/or Postoperative Pain Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.\n\nSubject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.\n\nHydrocodone/acetaminophen: Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.\n\nIbuprofen: 800 mg oral ibuprofen\n\nLorazepam: 2 mg oral lorazepam\n\nLidocaine: 20 ml 1% buffered lidocaine, injected'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.\n\nSubject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.\n\nPlacebo: Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.\n\nIbuprofen: 800 mg oral ibuprofen\n\nLorazepam: 2 mg oral lorazepam\n\nLidocaine: 20 ml 1% buffered lidocaine, injected'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)', 'description': 'To assess need for additional intraoperative and/or postoperative pain medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects in this study are women 18 years or older, recruited from OHSU and PPCW who present for an elective termination of pregnancy up to 10 weeks 6 days gestation'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', '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': '26.1', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '24.7', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '25.4', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2011-04-01', 'resultsFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-03', 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Perception of Pain', 'timeFrame': 'At time of uterine aspiration (baseline)', 'description': 'To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Patient Perception of Pain During Cervical Dilation', 'timeFrame': 'During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)', 'description': 'Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation'}, {'measure': 'Satisfaction With Pain Control', 'timeFrame': '30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)', 'description': 'Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure.'}, {'measure': 'Postoperative Nausea', 'timeFrame': '30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)', 'description': 'To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.'}, {'measure': 'Need for Additional Intraoperative and/or Postoperative Pain Medication', 'timeFrame': '30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)', 'description': 'To assess need for additional intraoperative and/or postoperative pain medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain during first trimester surgical abortion'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '17046383', 'type': 'BACKGROUND', 'citation': 'Allen RH, Kumar D, Fitzmaurice G, Lifford KL, Goldberg AB. Pain management of first-trimester surgical abortion: effects of selection of local anesthesia with and without lorazepam or intravenous sedation. Contraception. 2006 Nov;74(5):407-13. doi: 10.1016/j.contraception.2006.06.002. Epub 2006 Aug 2.'}, {'pmid': '2710563', 'type': 'BACKGROUND', 'citation': 'Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-350. doi: 10.1016/0304-3959(89)90094-8.'}, {'pmid': '3364636', 'type': 'BACKGROUND', 'citation': 'Bone ME, Dowson S, Smith G. A comparison of nalbuphine with fentanyl for postoperative pain relief following termination of pregnancy under day care anaesthesia. Anaesthesia. 1988 Mar;43(3):194-7. doi: 10.1111/j.1365-2044.1988.tb05538.x.'}, {'pmid': '10957701', 'type': 'BACKGROUND', 'citation': 'Dahl V, Fjellanger F, Raeder JC. No effect of preoperative paracetamol and codeine suppositories for pain after termination of pregnancies in general anaesthesia. Eur J Pain. 2000;4(2):211-5. doi: 10.1053/eujp.2000.0174.'}, {'pmid': '11408881', 'type': 'BACKGROUND', 'citation': 'Edelman A, Nichols MD, Jensen J. Comparison of pain and time of procedures with two first-trimester abortion techniques performed by residents and faculty. Am J Obstet Gynecol. 2001 Jun;184(7):1564-7. doi: 10.1067/mob.2001.114858.'}, {'pmid': '15172863', 'type': 'BACKGROUND', 'citation': 'Edelman A, Nichols MD, Leclair C, Astley S, Shy K, Jensen JT. Intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2004 Jun;103(6):1267-72. doi: 10.1097/01.AOG.0000127981.53911.0e.'}, {'pmid': '16449111', 'type': 'BACKGROUND', 'citation': 'Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2006 Feb;107(2 Pt 1):269-75. doi: 10.1097/01.AOG.0000194204.71925.4a.'}, {'pmid': '2619027', 'type': 'BACKGROUND', 'citation': 'Heath PJ, Ogg TW. Prophylactic analgesia for daycase termination of pregnancy. A double-blind study with controlled release dihydrocodeine. Anaesthesia. 1989 Dec;44(12):991-4. doi: 10.1111/j.1365-2044.1989.tb09206.x.'}, {'pmid': '14622683', 'type': 'BACKGROUND', 'citation': 'Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.'}, {'pmid': '15288222', 'type': 'BACKGROUND', 'citation': 'Kan AS, Ng EH, Ho PC. The role and comparison of two techniques of paracervical block for pain relief during suction evacuation for first-trimester pregnancy termination. Contraception. 2004 Aug;70(2):159-63. doi: 10.1016/j.contraception.2004.03.013.'}, {'type': 'BACKGROUND', 'citation': 'Nichols, M. D., Halvorson-Boyd, G., Goldstein, R., Gevirtz, C., & Healow, D. (2009). Pain management. In M. Paul, E. S. Lichtenberg, L. Borgatta, D. A. Grimes & P. G. Stubblefield (Eds.), Management of unintended and abnormal pregnancy. (pp. 90-110): Wiley-Blackwell.'}, {'pmid': '19341852', 'type': 'BACKGROUND', 'citation': "O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11."}, {'pmid': '19370649', 'type': 'BACKGROUND', 'citation': 'Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.'}, {'pmid': '18082668', 'type': 'BACKGROUND', 'citation': 'Romero I, Turok D, Gilliam M. A randomized trial of tramadol versus ibuprofen as an adjunct to pain control during vacuum aspiration abortion. Contraception. 2008 Jan;77(1):56-9. doi: 10.1016/j.contraception.2007.09.008. Epub 2007 Nov 26.'}, {'pmid': '11690725', 'type': 'BACKGROUND', 'citation': 'Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.'}, {'pmid': '18672118', 'type': 'BACKGROUND', 'citation': 'Singh RH, Ghanem KG, Burke AE, Nichols MD, Rogers K, Blumenthal PD. Predictors and perception of pain in women undergoing first trimester surgical abortion. Contraception. 2008 Aug;78(2):155-61. doi: 10.1016/j.contraception.2008.03.011. Epub 2008 May 27.'}, {'pmid': '6507524', 'type': 'BACKGROUND', 'citation': 'Suprapto K, Reed S. Naproxen sodium for pain relief in first-trimester abortion. Am J Obstet Gynecol. 1984 Dec 15;150(8):1000-1. doi: 10.1016/0002-9378(84)90399-5.'}, {'pmid': '8604867', 'type': 'BACKGROUND', 'citation': 'Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.'}, {'type': 'BACKGROUND', 'citation': 'Uppington, J. (2006). Opioids. In J. Ballantyne (Ed.), Massachusetts General Hospital Handbook of Pain Management (pp. 106-126). Philadelphia: Lippincott Williams & Wilkins.'}, {'pmid': '23700650', 'type': 'BACKGROUND', 'citation': 'Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK138196/'}, {'pmid': '12618257', 'type': 'BACKGROUND', 'citation': 'Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. doi: 10.1016/s0010-7824(02)00516-4.'}, {'pmid': '7556858', 'type': 'BACKGROUND', 'citation': 'Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. doi: 10.1016/0020-7292(95)02416-a.'}, {'pmid': '23090523', 'type': 'DERIVED', 'citation': 'Micks EA, Edelman AB, Renner RM, Fu R, Lambert WE, Bednarek PH, Nichols MD, Beckley EH, Jensen JT. Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1060-9. doi: 10.1097/aog.0b013e31826c32f0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.', 'detailedDescription': 'The investigators plan to conduct a double-blinded randomized placebo-controlled trial of 120 women undergoing elective first trimester surgical abortion. These women will be premedicated with either two tabs of 5/350 hydrocodone/acetaminophen or 2 tabs of a placebo. All subjects will receive ibuprofen and lorazepam preoperatively and a PCB. This study will examine the incremental benefit of HC/APAP over this standard medication regimen. Randomization will be stratified into two groups. Subjects less than 8 weeks gestation will comprise the early gestational age group. Subjects between 8 weeks 0 days and 10 weeks 6 days will comprise the late gestational age group. The investigators will be assessing patient perception of pain, nausea, satisfaction, and anxiety at multiple points during the clinic visit using 100-mm visual analogue scales (VAS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Voluntarily requesting surgical pregnancy termination\n* Pregnancy with intrauterine gestational sac up to 10 weeks 6 days gestation, dated by ultrasound\n* Eligible for suction curettage\n* English or Spanish speaking\n* Good general health\n* Able and willing to give informed consent and agree to terms of the study\n\nExclusion Criteria:\n\n* Gestational ages 11 weeks or more\n* Incomplete abortion\n* Premedication with misoprostol\n* Use of any opioid medication within the past 7 days\n* Use of heroin within the past 7 days\n* Requested opioids or IV sedation prior to start of the procedure\n* Patients who refuse ibuprofen or lorazepam\n* Contraindications or allergies to HC/APAP, lidocaine, ibuprofen, or lorazepam\n* Significant medical problem necessitating inpatient procedure\n* Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease\n* Known hepatic disease'}, 'identificationModule': {'nctId': 'NCT01330459', 'briefTitle': 'Hydrocodone For Pain Control in First Trimester Surgical Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion', 'orgStudyIdInfo': {'id': 'OHSU FAMPLAN 6734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrocodone/acetaminophen', 'description': 'Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.\n\nSubject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.', 'interventionNames': ['Drug: Hydrocodone/acetaminophen', 'Drug: Ibuprofen', 'Drug: Lorazepam', 'Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subject will receive placebo 45-90 minutes prior to abortion procedure.\n\nSubject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.', 'interventionNames': ['Drug: Placebo', 'Drug: Ibuprofen', 'Drug: Lorazepam', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Hydrocodone/acetaminophen', 'type': 'DRUG', 'otherNames': ['Vicodin'], 'description': 'Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.', 'armGroupLabels': ['Hydrocodone/acetaminophen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.', 'armGroupLabels': ['Placebo']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': '800 mg oral ibuprofen', 'armGroupLabels': ['Hydrocodone/acetaminophen', 'Placebo']}, {'name': 'Lorazepam', 'type': 'DRUG', 'description': '2 mg oral lorazepam', 'armGroupLabels': ['Hydrocodone/acetaminophen', 'Placebo']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': '20 ml 1% buffered lidocaine, injected', 'armGroupLabels': ['Hydrocodone/acetaminophen', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97206', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Planned Parenthood CW', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Elizabeth Micks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Micks', 'class': 'OTHER'}, 'collaborators': [{'name': 'Planned Parenthood Federation of America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Fellow in Family Planning', 'investigatorFullName': 'Elizabeth Micks', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}