REACT: Reducing anaesthetic complications in children undergoing tonsillectomies

Phase 4

Completed

• Conditions: Respiratory complications under general anaesthetic in children undergoing tonsillectomy (+/- adenoids/grommets) procedures.; Anaesthesiology - Anaesthetics; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12614000739617
• Lead Sponsor: Princess Margaret Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-11
• Study Completion: 2017-05-19
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

We will study 484 children, aged 0-8 years, undergoing general anaesthesia for elective tonsillectomy (+/- adenoidectomy, +/- grommets).
There will be two patient groups for the study:
Group one: Children 0-6 years old receiving an endotracheal tube (ETT)
Group two: Children 3-8 years old receiving a Laryngeal mask airway (LMA)

Exclusion Criteria

Children receiving a sedating premedication (e.g. midazolam, clonidine) before surgery.
Children with a known difficult airway or thoracic malformation.
Children with a known cardiopulmonary disease:
Uncorrected congenital heart disease
Primary/secondary pulmonary hypertension
Cardiac/thoracic malformations/tumours
Structural lung changes
The above list is a non-exhaustive list. Any other less common cardiopulmonary conditions will be assessed by the anaesthetist in charge and accounted for in the exclusion criteria list.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of Perioperative respiratory adverse events (PRAE) in children undergoing tonsillectomy receiving either a premedication of inhaled salbutamol or placebo as assessed via clinical assessments. PRAE include Bronchospasm, Laryngospasm, oxygen desaturation, airway obstruction, coughing and stridor.[Perioperative period until the patient is discharged from the Post anaesthesia Care Unit (PACU)]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is to reduce costs to the hospital by reducing time spent in the PACU due to PRAE. <br>[Lenght of time spent in PACU measured and recorded on PACU records and study data sheets.];The secondary outcome is to reduce costs to the hospital by reducing the number of unplanned admissions to the hospital due to PRAE. <br>[This will be measured in the patients notes in the post operative period.];The secondary outcome is to reduce costs to the hospital by reducing the prolonged hospital stays due to PRAE. <br>[Measured in the post operative period and as per detailed in the patients notes. ]