{ "FullStudy":{ "Rank":217799, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516684", "OrgStudyIdInfo":{ "OrgStudyId":"IRB00017079" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"NCI-2012-00019", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"CTRP (Clinical Trial Reporting Program)" },{ "SecondaryId":"CCCWFU 01211", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Wake Forest University Health Sciences" } ] }, "Organization":{ "OrgFullName":"Wake Forest University Health Sciences", "OrgClass":"OTHER" }, "BriefTitle":"Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures", "OfficialTitle":"A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream" }, "StatusModule":{ "StatusVerifiedDate":"August 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 14, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 26, 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 26, 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 27, 2019", "ResultsFirstSubmitQCDate":"August 12, 2019", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"September 6, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"August 12, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 6, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Wake Forest University Health Sciences", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Cancer Institute (NCI)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"No", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary", "DetailedDescription":"PRIMARY OBJECTIVES:\n\nI. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether the use of EMLA cream decreases complication rates from sedation.\n\nII. To determine whether the use of EMLA cream decreases traumatic lumbar punctures.\n\nIII. To determine whether the use of EMLA cream shortens recovery time. IV. To determine practitioner and parent satisfaction with the use of EMLA cream.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.\n\nARM II: Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.\n\nAfter completion of study treatment, patients are followed up within 1 week." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Malignant Neoplasm" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"33", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm I (EMLA)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: EMLA", "Drug: propofol", "Drug: fentanyl citrate" ] } },{ "ArmGroupLabel":"Arm II (placebo)", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: placebo administration", "Drug: propofol", "Drug: fentanyl citrate" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"placebo administration", "InterventionDescription":"Given topically", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm II (placebo)" ] } },{ "InterventionType":"Drug", "InterventionName":"EMLA", "InterventionDescription":"Given topically", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I (EMLA)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "eutectic mixture of local anesthetics", "lidocaine-prilocaine", "lidocaine-prilocaine eutectic mixture" ] } },{ "InterventionType":"Drug", "InterventionName":"propofol", "InterventionDescription":"Given IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I (EMLA)", "Arm II (placebo)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Diprivan" ] } },{ "InterventionType":"Drug", "InterventionName":"fentanyl citrate", "InterventionDescription":"Given IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I (EMLA)", "Arm II (placebo)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Actiq", "Oralet", "Sublimaze" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Total Dose of Propofol Administered to Each Patient", "PrimaryOutcomeDescription":"Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.", "PrimaryOutcomeTimeFrame":"20 minutes after sedation" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration", "SecondaryOutcomeTimeFrame":"At the time of LP insertion" },{ "SecondaryOutcomeMeasure":"Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream", "SecondaryOutcomeDescription":"Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any headache after the lumbar puncture, and if they had any other complications.", "SecondaryOutcomeTimeFrame":"Within one week of the LP" },{ "SecondaryOutcomeMeasure":"Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration", "SecondaryOutcomeDescription":"Traumatic lumbar puncture is defined as lumbar puncture in which cerebrospinal fluid contains at least 10 red blood cells (RBCs) per microliter and bloody lumbar as one in which the cerebrospinal fluid contained at least 500 red blood cells (RBCs) per microliter.", "SecondaryOutcomeTimeFrame":"20 minutes after lumbar puncture" },{ "SecondaryOutcomeMeasure":"Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream", "SecondaryOutcomeDescription":"Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any back pain after the lumbar puncture, and if they had any other complications.", "SecondaryOutcomeTimeFrame":"Within one week of the LP" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite; patients may or may not be receiving intrathecal chemotherapy\n\nExclusion Criteria:\n\nPatients undergoing additional procedures during the same anesthetic such as bone marrow aspirate or biopsy will be excluded because they will likely require higher doses of propofol than those undergoing LP alone Patients who are allergic to or not tolerant of EMLA cream, propofol, or fentanyl will be excluded Patients who are pregnant will be excluded Patients having their LPs done by students will be excluded", "HealthyVolunteers":"No", "Gender":"All", "MaximumAge":"22 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Dudley Hammon", "OverallOfficialAffiliation":"Wake Forest University Health Sciences", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Wake Forest University Health Sciences", "LocationCity":"Winston-Salem", "LocationState":"North Carolina", "LocationZip":"27157", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"Originally 33 participants were registered, with 170 trials; each participant had between 1-14 trials (median=4).\n\nFive of these participants did not end up receiving the procedure and 1 was a screen fail, leaving 27 participants with between 1-14 trials (median=5).", "FlowTypeUnitsAnalyzed":"Trials", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Arm A (EMLA)", "FlowGroupDescription":"Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Arm B (Placebo)", "FlowGroupDescription":"Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Overall number of units (trials) was used for measuring results with 170 trials.\n\nTrials were randomized for each arm, not participants", "FlowAchievementNumSubjects":"NA", "FlowAchievementNumUnits":"85" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Overall number of units (trials) was used for measuring results with 170 trials.\n\nTrials were randomized for each arm, not participants", "FlowAchievementNumSubjects":"NA", "FlowAchievementNumUnits":"85" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowMilestoneComment":"Overall number of units (trials) completed was 152", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Trials were randomized for each arm, not participants", "FlowAchievementNumSubjects":"NA", "FlowAchievementNumUnits":"75" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Overall number of units (trials) completed was 152\n\nTrials were randomized for each arm, not participants", "FlowAchievementNumSubjects":"NA", "FlowAchievementNumUnits":"77" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"NA", "FlowAchievementNumUnits":"10" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"NA", "FlowAchievementNumUnits":"8" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Participants were not randomized to the arms. The trials for each arm were randomized so we are using the trials to report demographics by arm.", "BaselineTypeUnitsAnalyzed":"Trials", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Arm A (EMLA)", "BaselineGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Arm B (Placebo)", "BaselineGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"NA" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"NA" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"NA" } ] } },{ "BaselineDenomUnits":"Trials", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"75" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"77" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"152" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineMeasureDenomUnitsSelected":"Trials", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7.7", "BaselineMeasurementSpread":"5.4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8.8", "BaselineMeasurementSpread":"5.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8.2", "BaselineMeasurementSpread":"5.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Units", "BaselineMeasureUnitOfMeasure":"Trials", "BaselineMeasureDenomUnitsSelected":"Trials", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"44" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"55" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"108" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity (NIH/OMB)", "BaselineMeasureDescription":"Participants were not randomized, the trials were randomized so we are using the trials (completed) to report demographics by arm", "BaselineMeasureParamType":"Count of Units", "BaselineMeasureUnitOfMeasure":"Trials", "BaselineMeasureDenomUnitsSelected":"Trials", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" } ] } },{ "BaselineCategoryTitle":"Not Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"65" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"67" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"132" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureDescription":"Participants were not randomized, the trials were randomized so we are using the trials (completed) to report demographics by arm", "BaselineMeasureParamType":"Count of Units", "BaselineMeasureUnitOfMeasure":"Trials", "BaselineMeasureDenomUnitsSelected":"Trials", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"60" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"56" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"116" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureDescription":"Participants were not randomized, the trials were randomized so we are using the trials (completed) to report demographics by arm", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Trials completed", "BaselineMeasureDenomUnitsSelected":"Trials", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"77" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"152" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Total Dose of Propofol Administered to Each Patient", "OutcomeMeasureDescription":"Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.", "OutcomeMeasurePopulationDescription":"Participants were not randomized. Trials were randomized so we will have to use the trials to report by arm", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"mg/kg", "OutcomeMeasureTimeFrame":"20 minutes after sedation", "OutcomeMeasureTypeUnitsAnalyzed":"Trials", "OutcomeMeasureDenomUnitsSelected":"Trials", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm A (EMLA)", "OutcomeGroupDescription":"Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm B (Placebo)", "OutcomeGroupDescription":"Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"NA" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"NA" } ] } },{ "OutcomeDenomUnits":"Trials", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"75" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"77" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.94", "OutcomeMeasurementSpread":"0.25" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.22", "OutcomeMeasurementSpread":"0.19" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.036", "OutcomeAnalysisStatisticalMethod":"T-test and chi-square" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration", "OutcomeMeasurePopulationDescription":"Participants were not randomized. Trials were randomized so we will use the trials to report by arm", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Units", "OutcomeMeasureUnitOfMeasure":"Trials", "OutcomeMeasureTimeFrame":"At the time of LP insertion", "OutcomeMeasureTypeUnitsAnalyzed":"Trials", "OutcomeMeasureDenomUnitsSelected":"Trials", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm A (EMLA)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm B (Placebo)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"NA" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"NA" } ] } },{ "OutcomeDenomUnits":"Trials", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"75" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"77" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"No movement", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"50" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"29" } ] } } ] } },{ "OutcomeClassTitle":"Minor movement", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12" } ] } } ] } },{ "OutcomeClassTitle":"Major movement", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27" } ] } } ] } },{ "OutcomeClassTitle":"Other", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream", "OutcomeMeasureDescription":"Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any headache after the lumbar puncture, and if they had any other complications.", "OutcomeMeasurePopulationDescription":"Not all procedures were completed at all trials. Participants were not randomized. Trials were randomized so will use the trials to report by arm.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Probability of experiencing headache", "OutcomeMeasureTimeFrame":"Within one week of the LP", "OutcomeMeasureTypeUnitsAnalyzed":"Trials", "OutcomeMeasureDenomUnitsSelected":"Trials", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm A (EMLA)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm B (Placebo)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"NA" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"NA" } ] } },{ "OutcomeDenomUnits":"Trials", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"68" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"73" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.194", "OutcomeMeasurementSpread":"0.041" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.289", "OutcomeMeasurementSpread":"0.057" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisNonInferiorityComment":"Marginal mixed model (GEE type)", "OutcomeAnalysisPValue":"0.094", "OutcomeAnalysisStatisticalMethod":"Mixed Models Analysis" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration", "OutcomeMeasureDescription":"Traumatic lumbar puncture is defined as lumbar puncture in which cerebrospinal fluid contains at least 10 red blood cells (RBCs) per microliter and bloody lumbar as one in which the cerebrospinal fluid contained at least 500 red blood cells (RBCs) per microliter.", "OutcomeMeasurePopulationDescription":"Total number of trials was 136, 15 are missing. Participants were not randomized. Trials were randomized so will use the trials to report by arm.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Units", "OutcomeMeasureUnitOfMeasure":"Trials", "OutcomeMeasureTimeFrame":"20 minutes after lumbar puncture", "OutcomeMeasureTypeUnitsAnalyzed":"Trials", "OutcomeMeasureDenomUnitsSelected":"Trials", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm A (EMLA)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm B (Placebo)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"NA" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"NA" } ] } },{ "OutcomeDenomUnits":"Trials", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"70" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"66" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Atraumatic", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"63" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"57" } ] } } ] } },{ "OutcomeClassTitle":"Traumatic", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Bloody", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.382", "OutcomeAnalysisStatisticalMethod":"Chi-squared" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream", "OutcomeMeasureDescription":"Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any back pain after the lumbar puncture, and if they had any other complications.", "OutcomeMeasurePopulationDescription":"Not all procedures were completed at all trials. Participants were not randomized. Trials were randomized so will use the trials to report by arm.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Probability of experiencing back pain", "OutcomeMeasureTimeFrame":"Within one week of the LP", "OutcomeMeasureTypeUnitsAnalyzed":"Trials", "OutcomeMeasureDenomUnitsSelected":"Trials", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm A (EMLA)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm B (Placebo)", "OutcomeGroupDescription":"Trials completed is the unit of measure, not participants.\n\nPatients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"NA" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"NA" } ] } },{ "OutcomeDenomUnits":"Trials", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"69" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"74" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.211", "OutcomeMeasurementSpread":"0.049" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.250", "OutcomeMeasurementSpread":"0.054" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisNonInferiorityComment":"Marginal mixed model (GEE type)", "OutcomeAnalysisPValue":"0.426", "OutcomeAnalysisStatisticalMethod":"Mixed Models Analysis" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Up to one week after lumbar puncture", "EventsDescription":"The principal investigator reports there were no adverse events during the randomized trials.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Arm A (EMLA)", "EventGroupDescription":"TRIALS COMPLETED is the unit of measure, not participants.\n\nPatients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"75", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"75", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"75" },{ "EventGroupId":"EG001", "EventGroupTitle":"Arm B (Placebo)", "EventGroupDescription":"TRIALS COMPLETED is the unit of measure, not participants.\n\nPatients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"77", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"77", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"77" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Thomas McLean", "PointOfContactOrganization":"Wake Forest University Health Sciences", "PointOfContactEMail":"tmclean@wakehealth.edu", "PointOfContactPhone":"336-716-5440" } } }, "DocumentSection":{ "LargeDocumentModule":{ "LargeDocList":{ "LargeDoc":[ { "LargeDocTypeAbbrev":"ICF", "LargeDocHasProtocol":"No", "LargeDocHasSAP":"No", "LargeDocHasICF":"Yes", "LargeDocLabel":"Informed Consent Form", "LargeDocDate":"August 26, 2015", 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