title: The design of a multicentre Canadian surveillance study of sedation safety in the paediatric emergency department.
abstract: BACKGROUND
  Procedural sedation and analgesia have become standard practice in paediatric emergency departments worldwide. Although generally regarded as safe, serious adverse events such as bradycardia, asystole, pulmonary aspiration, permanent neurological injury and death have been reported, but their incidence is unknown due to the infrequency of their occurrence and lack of surveillance of sedation safety. To improve our understanding of the safety, comparative effectiveness and variation in care in paediatric procedural sedation, we are establishing a multicentre patient registry with the goal of conducting regular and ongoing surveillance for adverse events in procedural sedation.
  
  
  METHODS
  This multicentre, prospective cohort study is enrolling patients under 18 years of age from six paediatric emergency departments across Canada. Data collection is fully integrated into clinical care and is performed electronically in real time by the healthcare professionals caring for the patient. The primary outcome is the proportion of patients who experience a serious adverse event as a result of their sedation. Secondary outcomes include the proportion of patients who experience an adverse event that could lead to a serious adverse event, proportion of patients who receive a significant intervention in response to an adverse event, proportion of patients who experience a successful sedation, and proportion of patients who experience a paradoxical reaction to sedation. There is no predetermined end date for data collection.
  
  
  BACKGROUND
  Ethics approval has been obtained from participating sites. Results will be disseminated using a multifaceted knowledge translation strategy by presenting at international conferences, publication in peer-reviewed journals, and through established networks.
authors.affiliation: University of Ottawa, Ottawa, Ontario, Canada Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
authors.forename: Maala
authors.initials: M
authors.lastname: Bhatt
authors.affiliation: University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota, USA.
authors.forename: Mark G
authors.initials: MG
authors.lastname: Roback
authors.affiliation: Univeristy of Western Ontario, London, Ontario, Canada Children's Hospital of Western Ontario, London Health Science Centre, London, Ontario, Canada.
authors.forename: Gary
authors.initials: G
authors.lastname: Joubert
authors.affiliation: University of Ottawa, Ottawa, Ontario, Canada Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
authors.forename: Ken J
authors.initials: KJ
authors.lastname: Farion
authors.affiliation: University of Alberta, Edmonton, Alberta, Canada Stollery Children's Hospital, Edmonton, Alberta, Canada.
authors.forename: Samina
authors.initials: S
authors.lastname: Ali
authors.affiliation: University of Toronto, Toronto, Ontario, Canada The Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Beno
authors.affiliation: Dalhousie University, Halifax, Nova Scotia, Canada IWK Health Center, Halifax, Nova Scotia, Canada.
authors.forename: C Michelle
authors.initials: CM
authors.lastname: McTimoney
authors.affiliation: University of Alberta, Edmonton, Alberta, Canada Stollery Children's Hospital, Edmonton, Alberta, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Dixon
authors.affiliation: McGill University, Montreal, Québec, Canada Montreal Children's Hospital-McGill University Health Centre, Montreal, Québec, Canada.
authors.forename: Alexander Sasha
authors.initials: AS
authors.lastname: Dubrovsky
authors.affiliation: University of Ottawa, Ottawa, Ontario, Canada Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.
authors.forename: Nick
authors.initials: N
authors.lastname: Barrowman
authors.affiliation: University of Calgary, Calgary, Alberta, Canada Alberta Children's Hospital, Calgary, Alberta, Canada.
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
mesh_terms: D000293:Adolescent; D002170:Canada; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D004632:Emergency Medical Services / Q000592:standards*; D004636:Emergency Service, Hospital; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects*; D007223:Infant; D010146:Pain / Q000523:psychology; D061214:Patient Safety / Q000592:standards*; D010372:Pediatrics / Q000592:standards*; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D018570:Risk Assessment; D059039:Standard of Care / Q000592:standards*
chemical_list: D006993:Hypnotics and Sedatives
keywords: Emergency medicine; Procedural sedation; pediatrics