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Clinical Trials/NCT04760249
NCT04760249CompletedNot Applicable

The Impact of a Dedicated Sedation Team on the Incidence of Complications in Paediatric Procedural Analgosedation

Universitätsklinikum Hamburg-Eppendorf0 sites784 target enrollmentStarted: September 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
784
Primary Endpoint
Incidence of adverse events

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours

Respiratory, hemodynamic, and other adverse events

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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