Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 1:03 PM
Study NCT ID:
NCT00588159
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kinney.michelle@mayo.edu', 'phone': '507-266-9877', 'title': 'Dr. Michelle A. O. Kinney', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours following entrance into the recovery room.', 'eventGroups': [{'id': 'EG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.', 'otherNumAtRisk': 57, 'otherNumAffected': 4, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.', 'otherNumAtRisk': 63, 'otherNumAffected': 4, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sedation', 'notes': 'Sedation was graded by nursing staff every 4 hours using the Pain Management Sedation Scale (0=awake; 1=drowsy, dozes intermittently, easily arousable; 2=sedated, sleeps, but can be aroused; 3=difficult to arouse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'OG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption in First 24 Hours Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'OG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '111.9', 'spread': '116.9', 'groupId': 'OG000'}, {'value': '118.1', 'spread': '94.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'OG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months postoperatively', 'description': 'Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Patients who rated their average pain 1 or greater were included.'}, {'type': 'PRIMARY', 'title': 'Average Pain Score With Coughing the First Morning Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'OG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First morning following surgery', 'description': 'Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).'}, {'type': 'PRIMARY', 'title': 'Average Pain Score With Coughing on Second Morning After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'OG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Second morning after surgery', 'description': 'Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.', 'unitOfMeasure': 'Unites on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy.Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'OG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '114.4', 'spread': '106.8', 'groupId': 'OG000'}, {'value': '121.6', 'spread': '110.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours postoperatively', 'description': 'Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'FG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gabapentin Preoperatively', 'description': 'Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.'}, {'id': 'BG001', 'title': 'Active Placebo', 'description': 'Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.'}, {'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': '33', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '7', 'groupId': 'BG000'}, {'value': '64', 'spread': '7', 'groupId': 'BG001'}, {'value': '64', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2007-12-18', 'resultsFirstSubmitDate': '2010-12-28', 'studyFirstSubmitQcDate': '2008-01-07', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-19', 'studyFirstPostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Pain Score at Rest', 'timeFrame': '48 hours', 'description': 'Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.'}, {'measure': 'Average Pain Score With Coughing the First Morning Following Surgery', 'timeFrame': 'First morning following surgery', 'description': 'Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.'}, {'measure': 'Average Pain Score With Coughing on Second Morning After Surgery', 'timeFrame': 'Second morning after surgery', 'description': 'Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption in First 24 Hours Postoperatively', 'timeFrame': '24 hours'}, {'measure': 'Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively', 'timeFrame': '3 months postoperatively', 'description': 'Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.'}, {'measure': 'Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively', 'timeFrame': '48 hours postoperatively', 'description': 'Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preoperative gabapentin', 'Acute pain', 'Post-thoracotomy pain', 'Epidural analgesia'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '21676165', 'type': 'DERIVED', 'citation': 'Kinney MA, Mantilla CB, Carns PE, Passe MA, Brown MJ, Hooten WM, Curry TB, Long TR, Wass CT, Wilson PR, Weingarten TN, Huntoon MA, Rho RH, Mauck WD, Pulido JN, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Shen KR, Wigle DA, Hoehn SL, Alexander SL, Hanson AC, Schroeder DR. Preoperative gabapentin for acute post-thoracotomy analgesia: a randomized, double-blinded, active placebo-controlled study. Pain Pract. 2012 Mar;12(3):175-83. doi: 10.1111/j.1533-2500.2011.00480.x. Epub 2011 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.', 'detailedDescription': 'The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 45-75 years\n* Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection)\n\nExclusion criteria:\n\n* Undergoing chest wall resection, gastroesophageal surgery\n* Enrolled in another post-thoracotomy analgesic research protocol\n* Pre-existing pain syndrome\n* Current gabapentin or pregabalin therapy\n* Inability to understand the study protocol\n* Coagulopathy\n* Current use of anticoagulants\n* Allergy to medications on protocol\n* Creatinine \\>1.3\n* Moderate or severe aortic stenosis\n* Severe psychological disorders\n* Bacteremia, osteomyelitis, or infection at site of thoracic epidural placement\n* History of previous thoracotomy\n* Patient declines preoperative epidural catheter placement\n* Prisoners or other institutionalized individuals\n* Severe hepatic, renal or cardiovascular disorders\n* Women who can become pregnant'}, 'identificationModule': {'nctId': 'NCT00588159', 'briefTitle': 'Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study', 'orgStudyIdInfo': {'id': '05-004145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin preoperatively', 'description': 'Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Active placebo', 'description': 'Diphenhydramine 12.5 mg orally 2 hours preoperatively.', 'interventionNames': ['Drug: Diphenhydramine']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': 'gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.', 'armGroupLabels': ['Gabapentin preoperatively']}, {'name': 'Diphenhydramine', 'type': 'DRUG', 'otherNames': ['Benadryl'], 'description': 'Diphenhydramine 12.5 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.', 'armGroupLabels': ['Active placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michelle A. Kinney, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michelle Kinney', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Michelle A. O. Kinney, MD', 'investigatorFullName': 'Michelle Kinney', 'investigatorAffiliation': 'Mayo Clinic'}}}}