Clinical trial NCT04760249: A Dedicated Sedation Team for Paediatric Procedural Sedation
Official title: The Impact of a Dedicated Sedation Team on the Incidence of Complications in Paediatric Procedural Analgosedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation Complication
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 784
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 1 day to 20 years

Brief summary: At a tertiary care university hospital a specialized interdisciplinary team of paediatric anaesthesiologists and paediatric intensivists was established for providing analgosedation for diagnostic and therapeutic procedures. The aim of the present study was to analyse the incidence and risk factors of adverse events during procedural sedation performed by the Children's Analgosedation Team (CAST).

Detailed description: At a tertiary care university hospital a dedicated Children's Analgosedation Team (CAST) performs all procedural sedations in children outside the operating room. Often patient age, comorbidities and procedures involving the airway are considered risk factors for adverse events, but previous studies investigating adverse events did not involve implementation of a specialised sedation team. Medical records of all children receiving procedural sedation by the CAST were reviewed for the incidence of adverse events. A bivariate analysis as well as an analysis of variance using type II Wald chi-square tests were conducted for identifying potential risk factors for adverse Events.

Eligibility criteria: Inclusion Criteria:

* Children (age 0-20 years) receiving procedural sedation
* Procedural sedation performed by the Children's Analgosedation Team

Exclusion Criteria:

* Missing medical records
* Procedural sedation not performed by the Children's Analgosedation Team

Primary outcomes:
measure: Incidence of adverse events
timeFrame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Secondary outcomes:
measure: Incidence of serious adverse events
timeFrame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
measure: Age
timeFrame: At the beginning of sedation (administration of 1. sedation drug)
measure: Sex
timeFrame: At the beginning of sedation (administration of 1. sedation drug)
measure: American Society of Anesthesiology (ASA) status
timeFrame: At the beginning of sedation (administration of 1. sedation drug)
measure: Date of sedation
timeFrame: At the beginning of sedation (administration of 1. sedation drug)
measure: Category of the primary diagnosis
timeFrame: At the beginning of sedation (administration of 1. sedation drug)
measure: Type and dose of sedative
timeFrame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
measure: Type and dose of analgesic
timeFrame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
measure: Upper respiratory tract infection (URI)
timeFrame: At the beginning of sedation (administration of 1. sedation drug)
Other outcomes:
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