A Dedicated Sedation Team for Paediatric Procedural Sedation
- Conditions
- Sedation Complication
- Registration Number
- NCT04760249
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 784
- Children (age 0-20 years) receiving procedural sedation
- Procedural sedation performed by the Children's Analgosedation Team
- Missing medical records
- Procedural sedation not performed by the Children's Analgosedation Team
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of 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 Respiratory, hemodynamic, and other adverse events
- Secondary Outcome Measures
Name Time Method American Society of Anesthesiology (ASA) status At the beginning of sedation (administration of 1. sedation drug) ASA physical status I / II / III / IV
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 Propofol or Midazolam in mg kg-1
Upper respiratory tract infection (URI) At the beginning of sedation (administration of 1. sedation drug) Signs of runny nose and/or cough
Age At the beginning of sedation (administration of 1. sedation drug) Patient age in month
Date of sedation At the beginning of sedation (administration of 1. sedation drug) Date as YEAR/MONTH/DAY
Category of the primary diagnosis At the beginning of sedation (administration of 1. sedation drug) Diagnosis that prompted the need for the procedure, categorized according to the subspecialty (hematology/oncology, nephrology, hepatology, gastroenterology, metabolic medicine, neurology, pulmonology, cardiology)
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 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
Sex At the beginning of sedation (administration of 1. sedation drug) Male or female
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 Esketamine in mg kg-1 or remifentanil in µg kg-1 min-1