A Dedicated Sedation Team for Paediatric Procedural Sedation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sedation Complication

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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) |