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Completed

NCT Number: NCT04760249

A Dedicated Sedation Team for Paediatric Procedural Sedation

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).

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Key information

Conditions

Sedation Complication

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Incidence of serious 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

    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

  2. Age

    Time frame: At the beginning of sedation (administration of 1. sedation drug)

    Patient age in month

  3. Sex

    Time frame: At the beginning of sedation (administration of 1. sedation drug)

    Male or female

  4. American Society of Anesthesiology (ASA) status

    Time frame: At the beginning of sedation (administration of 1. sedation drug)

    ASA physical status I / II / III / IV

  5. Date of sedation

    Time frame: At the beginning of sedation (administration of 1. sedation drug)

    Date as YEAR/MONTH/DAY

  6. Category of the primary diagnosis

    Time frame: 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)

  7. Type and dose of sedative

    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

    Propofol or Midazolam in mg kg-1

  8. Type and dose of analgesic

    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

    Esketamine in mg kg-1 or remifentanil in µg kg-1 min-1

  9. Upper respiratory tract infection (URI)

    Time frame: At the beginning of sedation (administration of 1. sedation drug)

    Signs of runny nose and/or cough

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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