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Trial registered on ANZCTR

Registration number

ACTRN12614000739617

Ethics application status

Approved

Date submitted

23/06/2014

Date registered

11/07/2014

Date last updated

24/01/2023

Date data sharing statement initially provided

24/01/2023

Date results provided

24/01/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

REACT: Reducing anaesthetic complications in children undergoing tonsillectomies

Scientific title

Does inhaled salbutamol decrease the incidence of perioperative respiratory adverse events in children undergoing tonsillectomy (+/- adenoids/grommets) procedures?

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

REACT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Respiratory complications under general anaesthetic in children undergoing tonsillectomy (+/- adenoids/grommets) procedures.

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will be recruited at the pre anaesthetic visit and randomised to receive either an inhaled placebo or inhaled salbutamol ( 200micrograms ventolin, GSK) via a metered dose inhaler (pMDI) and a spacer. The placebo/salbutamol will be administered in the 60 minutes prior to anaesthesia induction. The attending anaesthetists, the surgeon , anaesthetic technician, the nursing and recovery staff as well as the research staff will be blinded to the group allocation. Only the pharmacy will be unblinded.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Inhaled placebo administered via a metered dose inhaler (pMDI) and a spacer in the 60 minutes prior to anaesthesia induction.

Control group

Placebo

Outcomes

Primary outcome [1]

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.

Timepoint [1]

Perioperative period until the patient is discharged from the Post anaesthesia Care Unit (PACU)

Secondary outcome [1]

The secondary outcome is to reduce costs to the hospital by reducing time spent in the PACU due to PRAE.

Timepoint [1]

Lenght of time spent in PACU measured and recorded on PACU records and study data sheets.

Secondary outcome [2]

The secondary outcome is to reduce costs to the hospital by reducing the number of unplanned admissions to the hospital due to PRAE.

Timepoint [2]

This will be measured in the patients notes in the post operative period.

Secondary outcome [3]

The secondary outcome is to reduce costs to the hospital by reducing the prolonged hospital stays due to PRAE.

Timepoint [3]

Measured in the post operative period and as per detailed in the patients notes.

Eligibility

Key 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)

Minimum age

0 Years

Maximum age

8 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All patients will be recruited at the pre-anaesthetic visit. Only patients who meet the inclusion criteria for the study will be enrolled and only after informed consent is given voluntarily by the guardian and by the patient if appropriate. The patients will be randomised by computer generated block randomisation. The next available participant number will be assigned to the patient. The drug randomisation will be performed by pharmacy at Princess Margaret Hospital. The patient will receive the study drug corresponding with his/her Participant Number. The study drug is in boxes with patient numbers detailed on the outside. The participant number will be used to identify the patient for the duration of the study. All staff involved with the care of the patient and the data recording and entering will be blinded to the group allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated block randomisation.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The primary aim of this study is to investigate the difference in prevalence of PRAE between the intervention (salbutamol) and control (placebo) groups. This project will investigate the effects of salbutamol on PRAE, separately for the two different airway devices commonly used, an ETT will be used for 0-6 year old children and an LMA will be used for 3-8 year old children. In our recently completed randomised controlled trial involving tonsillectomy, the prevalence of PRAE was 48.2%. We aim to reduce the prevalence to 24.1% +/- 5%. We conservatively selected the upper limit of prevalence of 29.1% (24.1%+5%) for our power and sample size calculation. For the ETT group (for 0-6 year old children), we need 110 children for the intervention and the control groups, respectively, to detect a decreased prevalence of PRAE by 19% (48.2%-29.1%), with a power of 0.8 and at the significance of 0.05. Likewise for our study purpose in the LMA group (for 3-8 year old children), we need the same number of children (n=110) in the intervention and control groups, respectively. Therefore we require 440 children to take part in this project. Furthermore, based on our previous experience, approximately 10% of the data will not be usable due to changes in clinical requirements for the particular patients or due to patient withdrawal and we thus have to add 10% to our sample size calculation to keep the study appropriately powered. We will therefore recruit 484 patients.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

22/07/2014

Actual

15/07/2014

Date of last participant enrolment

Anticipated

30/06/2017

Actual

18/05/2017

Date of last data collection

Anticipated

Actual

19/05/2017

Sample size

Target

484

Accrual to date

Final

484

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Princess Margaret Hospital Foundation

Address [1]

68 Hay street
Subiaco
WA 6008

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Margaret Hospital

Address

Roberts Road
Subiaco
WA 6008

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Not applicable.

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital for Children Ethics Committee

Ethics committee address [1]

Roberts Road
Subiaco
WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/05/2014

Ethics approval number [1]

EP2014042

Summary

Brief summary

Despite the development of anaesthesia management guidelines, PRAE remain a major cause of morbidity and mortality during paediatric anaesthesia, accounting for more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. 
It is known that the rate of PRAE is approximately 2-folds higher in children undergoing tonsillectomy procedures compared to adults and that the rate of complications is also inversely proportional to age. Younger children are at a higher risk for PRAE compared with older children with a decrease in PRAE of 11% with each yearly increase in age.  
In recent studies and audits in our institution looking at children undergoing tonsillectomies, we found that approximately half the patients suffer from PRAE. Such a high rate of complications inevitably generates a cascade of linked events such as delays in theatre, with the potential for cancellation of other children due to the lack of theatre time and consecutive increases in waitlist time, unplanned hospital admissions, prolonged hospital stay and additional treatment. Even though most PRAE are not associated with long-term sequelae, it also creates more stress for the child and parents. Furthermore, data from closed malpractice claims in the United States of America (USA) show that nearly half of all claims were due to PRAE with higher incidents of death and brain damage as well as higher compensation payments in children as compared with adults. 
The development of preventative strategies, incorporated into an optimised anaesthesia management, would help reduce the occurrence of PRAE and address the previously cited issues. Salbutamol is a commonly used drug in the treatment of asthma which is available as an over the counter medication in Australia. A previous observational trial showed that premedication with inhaled salbutamol reduced the incidence of respiratory adverse events and in particular reduced bronchospasm and persistent cough by up to 50% in children with a recent upper respiratory tract infection. This current study aims to test the efficacy of inhaled salbutamol to prevent PRAE in young children undergoing tonsillectomies, who are at a particularly high risk for PRAE in a randomised controlled setting. The secondary objectives are to reduce the delays in theatre and the time spent in PACU due to PRAE, the number of unplanned admissions, prolonged hospital stays and delays in the waiting lists due to sequelae following PRAE. 

Hypothesis
We hypothesise that, in children undergoing tonsillectomy (+/- adenoidectomy, +/- grommets) procedures, the incidence of overall PRAE will be significantly reduced by the preoperative treatment with inhaled salbutamol as compared with placebo.

Trial website

Not applicable

Trial related presentations / publications

Not applicable

Public notes

Contacts

Principal investigator

Name

Prof Britta Regli-von Ungern-Sternberg

Address

Department of Anaesthesia and Pain Management Princess Margaret
Hospital for Children Roberts Road Subiaco WA 6008

Country

Australia

Phone

+61893408109

Fax

[email protected]

Contact person for public queries

Name

Britta Regli-von Ungern-Sternberg

Address

Department of Anaesthesia and Pain Management Princess Margaret
Hospital for Children Roberts Road Subiaco WA 6008

Country

Australia

Phone

+61893408109

Fax

[email protected]

Contact person for scientific queries

Name

Britta Regli-von Ungern-Sternberg

Address

Department of Anaesthesia and Pain Management Princess Margaret
Hospital for Children Roberts Road Subiaco WA 6008

Country

Australia

Phone

+61893408109

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of Albuterol Premedication vs Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: The REACT Randomized Clinical Trial.	2019	https://dx.doi.org/10.1001/jamapediatrics.2019.0788

N.B. These documents automatically identified may not have been verified by the study sponsor.

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