A Dedicated Sedation Team for Paediatric Procedural Sedation

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760249
• Other study ID #: CAST-01
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: December 31, 2015

Study information

• Verified date: February 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 784
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sedation Complication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Age	Patient age in month	At the beginning of sedation (administration of 1. sedation drug)
Secondary	Sex	Male or female	At the beginning of sedation (administration of 1. sedation drug)
Secondary	American Society of Anesthesiology (ASA) status	ASA physical status I / II / III / IV	At the beginning of sedation (administration of 1. sedation drug)
Secondary	Date of sedation	Date as YEAR/MONTH/DAY	At the beginning of sedation (administration of 1. sedation drug)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Upper respiratory tract infection (URI)	Signs of runny nose and/or cough	At the beginning of sedation (administration of 1. sedation drug)