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A Dedicated Sedation Team for Paediatric Procedural Sedation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04760249
Enrollment
784
Registered
2021-02-18
Start date
2015-09-01
Completion date
2015-12-31
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation Complication

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.

Interventions

None listed

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of adverse eventsFrom the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hoursRespiratory, hemodynamic, and other adverse events

Secondary

MeasureTime frameDescription
AgeAt the beginning of sedation (administration of 1. sedation drug)Patient age in month
SexAt the beginning of sedation (administration of 1. sedation drug)Male or female
American Society of Anesthesiology (ASA) statusAt the beginning of sedation (administration of 1. sedation drug)ASA physical status I / II / III / IV
Date of sedationAt the beginning of sedation (administration of 1. sedation drug)Date as YEAR/MONTH/DAY
Incidence of serious adverse eventsFrom the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hoursAspiration, 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
Type and dose of sedativeFrom the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hoursPropofol or Midazolam in mg kg-1
Type and dose of analgesicFrom the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hoursEsketamine in mg kg-1 or remifentanil in µg kg-1 min-1
Upper respiratory tract infection (URI)At the beginning of sedation (administration of 1. sedation drug)Signs of runny nose and/or cough
Category of the primary diagnosisAt 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026