{
  "FullStudy":{
    "Rank":217997,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514097",
          "OrgStudyIdInfo":{
            "OrgStudyId":"1112-120"
          },
          "Organization":{
            "OrgFullName":"Children's Hospitals and Clinics of Minnesota",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Adequacy of Pain Management for Upper Extremity Fracture After Discharge From a Pediatric Emergency Depart"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2014",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2016",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2016",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 29, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 30, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Children's Hospitals and Clinics of Minnesota",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Pain is a common cause for children seeking care in the Emergency Department (ED). Children with orthopedic injuries often require pain control when seeking emergency care. Despite the high prevalence of ED visits requiring pain control, pain is often poorly assessed and treated in ED settings. Currently, no standard of care exists for the management of this fracture-related pain in children discharged from the ED. Furthermore, discrepancies in analgesia administration to patients of various racial groups seeking emergency care have been documented but are poorly understood. No research currently exists comparing pain severity between upper extremity fractures requiring simple splinting to those treated with sedated reduction and splinting. Furthermore, there is no research regarding the prevalence of significant post-discharge pain nor the differences among ethnic and age groups treated in the ED.\n\nResearch Questions:\n\nWhat is the prevalence of significant post-discharge pain in children treated for upper extremity fractures?\n\nIs there a difference in severity between those children requiring reduction versus simple splinting?\n\nIs there a difference in pain severity noted among different ethnic or age groups?\n\nDesign This is a prospective, un-blinded, observational study that will include patients seeking treatment for an upper extremity fracture."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Fracture"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "emergency",
              "pediatric",
              "fracture",
              "pain"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"300",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Fractures reduced"
              },{
                "ArmGroupLabel":"Fractures splinted"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Pain Score",
                "PrimaryOutcomeDescription":"Numeric pain scale from 0 - 10. 10 indicating the worst pain",
                "PrimaryOutcomeTimeFrame":"day 2 - 3"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Second pain score assessment",
                "SecondaryOutcomeDescription":"Numeric pain scale from 0 - 10. 10 indicating the worst pain",
                "SecondaryOutcomeTimeFrame":"7-8 days after ED discharge"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nParents/guardians of patients presenting to the ED will be included if:\nThe patient is younger than 18 years old\nThe patient has an isolated upper extremity fracture (including clavicle, humerus, forearm, wrist) undergoing ED splinting with or without reduction\nThe parent/guardian is English, Spanish, Somali, or Hmong-speaking\nThe parent/guardian lives with the child\nHe/she has a working telephone number\n\nExclusion Criteria:\n\nPotential subjects presenting to the ED will be excluded from study participation if:\nThere is suspicion of child abuse or neglect\nThe parent/guardian is not English, Spanish, Somali, or Hmong-speaking\nThe patient is critically ill\nThe fracture requires operative reduction/treatment\nThe patient is medically complex\nThe patient has a pre-existing bone disease or chronic pain syndrome",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"17 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          },
          "StudyPopulation":"Pediatric emergency department",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Children's Hospitals and Clinics of Minnesota",
                "LocationStatus":"Recruiting",
                "LocationCity":"Twin Cities",
                "LocationState":"Minnesota",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Heidi Vander Velden, MS",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"612-813-7892"
                    },{
                      "LocationContactName":"Henry Ortega, MD",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Sam Reid, MD",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000050723",
                "ConditionMeshTerm":"Fractures, Bone"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014947",
                "ConditionAncestorTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M24957",
                "ConditionBrowseLeafName":"Fractures, Bone",
                "ConditionBrowseLeafAsFound":"Fracture",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6379",
                "ConditionBrowseLeafName":"Emergencies",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}