A Dedicated Sedation Team for Paediatric Procedural Sedation

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

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).

Study Overview

• Status: Completed
• Conditions: Sedation Complication

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 Type: Observational
• Enrollment (Actual): 784

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children from 1 day to 20 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Respiratory, hemodynamic, and other 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events	Aspiration, vomiting/regurgitation, desaturation < 90% for > 30sec, hypotension < 50% of baseline, laryngospasm, thorax rigidity, unplanned admission to Paediatric Intensive Care Unit (PICU), cardiac arrest, and death	From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Age	Patient age in month	At the beginning of sedation (administration of 1. sedation drug)
Sex	Male or female	At the beginning of sedation (administration of 1. sedation drug)
American Society of Anesthesiology (ASA) status	ASA physical status I / II / III / IV	At the beginning of sedation (administration of 1. sedation drug)
Date of sedation	Date as YEAR/MONTH/DAY	At the beginning of sedation (administration of 1. sedation drug)
Category of the primary diagnosis	Diagnosis that prompted the need for the procedure, categorized according to the subspecialty (hematology/oncology, nephrology, hepatology, gastroenterology, metabolic medicine, neurology, pulmonology, cardiology)	At the beginning of sedation (administration of 1. sedation drug)
Type and dose of sedative	Propofol or Midazolam in mg kg-1	From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Type and dose of analgesic	Esketamine in mg kg-1 or remifentanil in µg kg-1 min-1	From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours
Upper respiratory tract infection (URI)	Signs of runny nose and/or cough	At the beginning of sedation (administration of 1. sedation drug)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: February 7, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CAST-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No