Prevalence and predictors of complications during sedation for paediatric gastrointestinal endoscopy

Prevalence and predictors of adverse respiratory events during deep sedation using native airway for paediatric gastrointestinal endoscopy in lateral position

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN70362666

Enrollment

3000

Registered

2017-01-20

Start date

2016-04-20

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

Respiratory complications Respiratory Respiratory complications

Interventions

Medical records of all children up to the age of 16 years who required in- or outpatient procedural deep sedation and analgesia between January 1, 2010 and August 31, 2016 will be retrieved from the h

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children up to the age of 16 years 2. Required in- or outpatient procedural deep sedation and analgesia for an elective or diagnostic gastrointestinal endoscopy between January 1, 2010 and August 31, 2016

Exclusion criteria

Exclusion criteria: 1. Children presenting with an American Society of Anaesthesiologists physical status classification = IV 2. Ventilated children 3. Children already receiving sedative medications prior to sedation procedure 4. Children requiring therapeutic or urgent gastrointestinal endoscopy

Design outcomes

Primary

Measure	Time frame
Prevalence and predictors of respiratory complications during paediatric gastrointestinal endoscopy in lateral position is assessed through medical record review at the end of the study.	—

Secondary

Measure	Time frame
1. Association between the type of sedative(s) used, dosage of induction agents administered and the adverse respiratory event experience is assessed through medical record review at the end of the study 2. Most appropriate induction dose of sedative(s) in normal- weight (mg per kg current body weight), obese and morbidly obese children (mg per kg current body weight and mg per kg ideal body weight) is assessed through medical record review at the end of the study 3. Ease of performing the procedure as satisfactory, difficult or impossible and the reason for this is assessed through medical record review at the end of the study 4. Failure rate and reason of this (e.g. inappropriate sedation or complications) is assessed through medical record review at the end of the study 5. Prevalence of post procedural nausea, vomiting and agitation is assessed through medical record review at the end of the study 6. Sedation time (time required to complete procedures), time to recovery and time to discharge is assessed through medical record review at the end of the study 7. Prevalence of any unplanned escalation of care e.g. transfer from the ward to the paediatric intensive care unit or prolonged hospitalization is assessed through medical record review at the end of the study	—

Measure

Time frame

1. Association between the type of sedative(s) used, dosage of induction agents administered and the adverse respiratory event experience is assessed through medical record review at the end of the study 2. Most appropriate induction dose of sedative(s) in normal- weight (mg per kg current body weight), obese and morbidly obese children (mg per kg current body weight and mg per kg ideal body weight) is assessed through medical record review at the end of the study 3. Ease of performing the procedure as satisfactory, difficult or impossible and the reason for this is assessed through medical record review at the end of the study 4. Failure rate and reason of this (e.g. inappropriate sedation or complications) is assessed through medical record review at the end of the study 5. Prevalence of post procedural nausea, vomiting and agitation is assessed through medical record review at the end of the study 6. Sedation time (time required to complete procedures), time to recovery and time to discharge is assessed through medical record review at the end of the study 7. Prevalence of any unplanned escalation of care e.g. transfer from the ward to the paediatric intensive care unit or prolonged hospitalization is assessed through medical record review at the end of the study

—

Countries

Belgium

Contacts

Public ContactVeerle Van Mossevelde

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026