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Procedural Sedation Outside the Operating Room Using Ketamine in 22,645 Children: A Report from the Pediatric Sedation Research ConsortiumJocelyn R. Grunwell, Curtis Travers, Courtney E. McCracken, Patricia D. Scherrer, Anne G. Stormorken, Corrie E. Chumpitazi, Mark G. Roback, Jana A. Stockwell, and Pradip P. KamatSupplementary InformationeTable1. Centers Participating in the Pediatric Sedation Research ConsortiumeTable2. Definition of Adverse Events from the Pediatric Sedation Research ConsortiumeTable3. Painful Procedures for Which Pediatric Sedation Was ProvidedeTable 4. Adverse Events and Severe Adverse Events by Age GroupeTable 1. Centers Participating in the Pediatric Sedation Research ConsortiumAkron Children’s Hospital, Akron, OHAmerican Family Children’s Hospital, Madison, WIAnn & Robert Lurie Children’s Hospital of Chicago, Chicago, ILAvera McKennan Hospital, Sioux Falls, SDBlank Children’s Hospital, Iowa Methodist Medical Center, Des. Moines, IACape Fear Valley Children’s Hospital, Fayetteville, NCChildren’s Hospital Colorado, Aurora, COChildren’s of Alabama, Birmingham, ALChildren’s Healthcare of Atlanta at Egleston, Emory University School of Medicine, Atlanta, GAChildren’s Healthcare of Atlanta at Scottish Rite, Atlanta, GAChildren’s Hospital and Clinics of Minnesota, Minneapolis, MNChildren’s Hospital of the Greenville Hospital System, Greenville, SCChildren’s Hospital of Illinois, Peoria, ILChildren’s Hospital of The King’s Daughters, Norfolk, VAChildren’s Hospital at Memorial University Medical Center, Savannah, GAChildren’s Hospital Navicent Health, Macon, GAChildren’s Hospital of San Antonio, San Antonio, TXConnecticut Children’s, Hartford, CTCook Children’s Hospital, Fort Worth, TXDoernbecher Children’s Hospital, Portland, ORDuke University Medical Center, Durham, NCEastern Maine Medical Center, Bangor, MEFlorida Hospital for Children, Orlando, FLGolisano Children’s Hospital of SW Florida, Fort Myers, FLHelen Devos Children’s Hospital, Grand Rapids, MIHoltz Children’s Hospital, Miami, FLJames and Connie Maynard Children’s Hospital, Greenville, NCKentucky Children’s Hospital, Lexington, KYKosair Children’s Hospital, Louisville, KYMaricopa Integrated Health System, Phoenix, AZMemorial Children’s Hospital, South Bend, INNemours Foundation Al DuPont Hospital, Wilmington, DERainbow Babies and Children’s Hospital, Cleveland, OHRiley Hospital for Children at IndianaUniversity Health, Indianapolis, INSSM Cardinal Glennon Children’s Hospital, Olivette, MOSt. Vincent Hospital Hospital, Green Bay, WITexas Children’s, Houston, TXThe Children’s Hospital at Providence, Anchorage, AKUniversity of Chicago Comer’s Children’s Hospital, Chicago, ILUNC Health Care, Chapel Hill, NC Vanderbilt University Medical Center, Nashville, TNWakeMed Children’s Hospital, Raleigh, NCWVU Children’s Hospital, Morgantown, WVYale New Haven Children’s Hospital, New Haven, CTeTable 2. Definition of Adverse Events from the Pediatric Sedation Research ConsortiumAdverse EventAgitation/DeliriumAirway obstruction (no air movement for ≥ 15 sec despite respiratory effort)aAllergic reactionApnea > 15 secAspirationaCardiac arrestaCoughingDeathaDesaturation, O2 Sat < 90% for > 30 secEmergency anesthesia consultationaEmergent airway interventionaHypothermiaInadequate sedationIV-related complicationLaryngospasmaSecretions excessive enough to require treatmentStridorUnexpected change in heart rate or blood pressure > 30% of baselinebUnplanned admission to hospital or increase in level of careaUse of reversal agents – unplannedVomiting (non-gastrointestinal procedure)WheezingOtheraDefined as a severe adverse event.bHypertension, hypotension, tachycardia, and bradycardia not present prior to sedation and temporally related to sedation.eTable 3. Painful Procedures for Which Pediatric Sedation Was ProvidedProcedure CategoryBone and Joint/SkeletalFracture reductionJoint injection/aspirationJoint reductionPin removal/placementOther bone joint/skeletal procedureCardiacCardiac catheterizationCardioversionElectrophysiology study/ablationPericardiocentesisTransesophageal echocardiogramOther cardiology procedureGastroenterologyCecostomy change/placementLiver biopsyPercutaneous endoscopic gastrostomy/gastrostomy tube placement/changeUpper endoscopyOther gastroenterology procedureHematology/oncologyBone marrow aspirateOmmaya reservoir tap or medication installation/biopsyLumbar puncture/Intrathecal medication administrationRadiologicalPeripherally inserted central catheter placementOtherRenal biopsySurgical procedureDental examination/treatmentProcedure deemed painfuleTable 4. Adverse Events and Severe Adverse Events by Age GroupAEAgep-value0-3 Monthsn = 325 (1.4%)4-12 Monthsn = 1,691(7.5%)1-13 Yearsn = 17,781(78.5%)> 13 Yearsn = 2848(12.6%)Any AE30 (9.2%)130 (7.7%)1,228 (6.9%)255 (8.9%)<0.001Any SAE6 (1.9%)30 (1.8%)316 (1.8%)49 (1.7%)0.997Desaturation14 (4.3%)39 (2.3%)324 (1.8%)54 (1.9%)0.001Vomiting1 (0.3%)3 (0.2%)195 (1.1%)42 (1.5%)<0.001Agitation / Delirium5 (1.5%)10 (0.6%)114 (0.6%)29 (1.0%)0.035Other3 (0.9%)18 (1.1%)110 (0.6%)28 (1.0%)0.038*Airway Obstruction3 (0.9%)11 (0.7%)192 (1.1%)29 (1.0%)0.419Secretions0 (0.0%)21 (1.2%)127 (0.7%)12 (0.4%)0.006Coughing0 (0.0%)17 (1.0%)140 (0.8%)17 (0.6%)0.176IV Related1 (0.3%)22 (1.3%)117 (0.7%)11 (0.4%)0.003Unexpected change in HR, BP > 30%4 (1.2%)4 (0.2%)72 (0.4%)37 (1.3%)<0.001*Emergent Airway4 (1.2%)17 (1.0%)124 (0.7%)23 (0.8%)0.349Apnea7 (2.2%)15 (0.9%)101 (0.6%)29 (1.0%)0.007*Laryngospasm1 (0.3%)4 (0.2%)83 (0.5%)3 (0.1%)0.025Not Completed0 (0.0%)10 (0.7%)27 (0.2%)2 (0.1%)<0.001Allergic Reaction0 (0.0%)1 (0.1%)16 (0.1%)4 (0.1%)0.782*Unplanned Admission2 (0.6%)4 (0.2%)14 (0.1%)3 (0.1%)0.014*Italicized text denotes serious complication. ................
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