Lippincott Williams & Wilkins



Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report from the Pediatric Sedation Research ConsortiumJocelyn R. Grunwell, MD, PhD, Anne G. Stormorken, MD , Curtis Travers, MPH, Patricia D. Scherrer, MD, Corrie E. Chumpitazi, MD, Jana A. Stockwell, MD, Mark G. Roback, MD, Joseph Cravero, MD, and Pradip P Kamat, MD, MBASupplementary InformationeTable 1. Centers Participating in the Pediatric Sedation Research ConsortiumeTable 2. Definition of Adverse Events from the Pediatric Sedation Research ConsortiumeTable 3. Painful Procedures for Which Pediatric Sedation Was ProvidedeFigure 1. Number of Sites Contributing Ketamine + Propofol Data by Study PeriodeTable 4. AE and SAE for Ketamine + Propofol, Ketamine + Propofol and Anticholinergic, and Ketamine + Propofol and BenzodiazepineeTable 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 painfuleFigure 1. Number of ketamine + propofol sedations and contribution to total sedation records by study period and site. A) Earlier cohort from September 2007 – November 2011 comprised of 29 sites, B) Latter cohort from December 2011 – November 2015 comprised of 48 sites.eTable 4. Adverse Events and Severe Adverse Events for all combinations of Ketamine + Propofol (KP), + Anticholinergic (A), and/or + Benzodiazepine (B). CharacteristicKP(n = 3,660)KPB(n = 2,557)KPA(n = 611)KPBA(n = 417)p-valueAny Adverse Eventa369 (10.1%)152 (5.9%)119 (19.5%)67 (16.1%)<0.001Desaturation140 (3.8%)63 (2.4%)41 (6.7%)34 (8.2%)<0.001Cough53 (1.5%)10 (0.4%)22 (3.6%)19 (4.6%)<0.001Apnea > 15 seconds87 (2.4%)7 (0.3%)16 (2.6%)5 (1.2%)<0.001Secretions39 (1.1%)17 (0.7%)19 (3.1%)14 (3.4%)<0.001IV Related11 (0.3%)8 (0.3%)1 (0.2%)2 (0.5%)0.827Unexpected change in HR, BP > 30%25 (0.7%)22 (0.9%)13 (2.1%)3 (0.7%)0.005Other21 (0.6%)19 (0.7%)5 (0.8%)5 (1.2%)0.387Agitation/Delirium16 (0.4%)9 (0.4%)4 (0.7%)2 (0.5%)0.658Vomiting8 (0.2%)1 (0.0%)1 (0.2%)4 (1.0%)0.005Not completed (n = 6,645)5 (0.1%)5 (0.2%)2 (0.4%)1 (0.3%)0.362Wheezing5 (0.1%)1 (0.0%)2 (0.3%)2 (0.5%)0.051Any Serious Adverse Eventa, b129 (3.5%)30 (1.2%)75 (12.3%)19 (4.6%)<0.001Airway Obstruction66 (1.8%)17 (0.7%)50 (8.2%)10 (2.4%)<0.001Emergent Airway62 (1.7%)8 (0.3%)39 (6.4%)9 (2.2%)<0.001Laryngospasm18 (0.5%)10 (0.4%)19 (3.1%)4 (1.0%)<0.001Unplanned Admission5 (0.1%)1 (0.0%)2 (0.3%)3 (0.7%)0.012Emergency Anesthesia4 (0.1%)0 (0.0%)1 (0.2%)1 (0.2%)0.085Aspiration1 (0.0%)0 (0.0%)1 (0.2%)0 (0.0%)0.263Cardiac Arrest1 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)1.000 ................
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