{ "FullStudy":{ "Rank":217991, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514175", "OrgStudyIdInfo":{ "OrgStudyId":"KACW1" }, "Organization":{ "OrgFullName":"Culpeper Surgery Center", "OrgClass":"OTHER" }, "BriefTitle":"A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac", "OfficialTitle":"A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac" }, "StatusModule":{ "StatusVerifiedDate":"May 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Enrolling by invitation", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 2012", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"June 14, 2011", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 15, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 16, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Khalid Athar M.D.", "ResponsiblePartyInvestigatorTitle":"Medical Director", "ResponsiblePartyInvestigatorAffiliation":"Culpeper Surgery Center" }, "LeadSponsor":{ "LeadSponsorName":"Culpeper Surgery Center", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Cumberland Pharmaceuticals", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).", "DetailedDescription":"The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).\n\nThe secondary objectives of this study are:\n\nTo compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.\nTo compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.\nTo compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.\nTo compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chronic Pelvic Pain" ] }, "KeywordList":{ "Keyword":[ "Ketorolac", "Caldolor", "Chronic Pelvic Pain" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"ibuprofen versus ketoralac", "ArmGroupType":"Experimental", "ArmGroupDescription":"IV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia. A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: IV Ibuprofen", "Drug: IV Ketorolac" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"IV Ibuprofen", "InterventionDescription":"Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "ibuprofen versus ketoralac" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "IV Caldolor" ] } },{ "InterventionType":"Drug", "InterventionName":"IV Ketorolac", "InterventionDescription":"Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "ibuprofen versus ketoralac" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "IV Toradol" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).", "PrimaryOutcomeTimeFrame":"One Year" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups", "SecondaryOutcomeTimeFrame":"1 Year" },{ "SecondaryOutcomeMeasure":"Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups", "SecondaryOutcomeTimeFrame":"One Year" },{ "SecondaryOutcomeMeasure":"Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups", "SecondaryOutcomeTimeFrame":"One Year" },{ "SecondaryOutcomeMeasure":"Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups", "SecondaryOutcomeTimeFrame":"One Year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery\n\nExclusion Criteria:\n\nInadequate IV access.\nHistory of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.\nLess than 18 years of age or Greater than 65 years of age.\nUse of analgesics, including NSAIDs, less than 12 hours prior to surgery.\nPatients with active, clinically significant anemia.\nHistory or evidence of asthma or heart failure.\nPregnant.\nInability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.\nRefusal to provide written authorization for use and disclosure of protected health information.\nPatients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain.\nPatients with known OSA", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Khalid Athar, MD", "OverallOfficialAffiliation":"Culpeper Regional Health Systems", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Culpeper Surgery Center", "LocationCity":"Culpeper", "LocationState":"Virginia", "LocationZip":"22701", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007052", "InterventionMeshTerm":"Ibuprofen" },{ "InterventionMeshId":"D000020910", "InterventionMeshTerm":"Ketorolac" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000016861", "InterventionAncestorTerm":"Cyclooxygenase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M21229", "InterventionBrowseLeafName":"Ketorolac", "InterventionBrowseLeafAsFound":"Ketorolac", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8685", "InterventionBrowseLeafName":"Ibuprofen", "InterventionBrowseLeafAsFound":"Ibuprofen", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M21230", "InterventionBrowseLeafName":"Ketorolac Tromethamine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2799", "InterventionBrowseLeafName":"Anti-Inflammatory Agents, Non-Steroidal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19370", "InterventionBrowseLeafName":"Analgesics, Non-Narcotic", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M17792", "InterventionBrowseLeafName":"Cyclooxygenase Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000017699", "ConditionMeshTerm":"Pelvic Pain" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010146", "ConditionAncestorTerm":"Pain" },{ "ConditionAncestorId":"D000009461", "ConditionAncestorTerm":"Neurologic Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18501", "ConditionBrowseLeafName":"Pelvic Pain", "ConditionBrowseLeafAsFound":"Pelvic Pain", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10987", "ConditionBrowseLeafName":"Neurologic Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" } ] } } } } } }