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REACT: Reducing anaesthetic complications in children undergoing tonsillectomies

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000739617
Acronym
REACT
Enrollment
484
Registered
2014-07-11
Start date
2014-07-15
Completion date
2017-05-18
Last updated
2023-01-30

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

Conditions

None listed

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.

Interventions

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 wi

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.

Sponsors

Princess Margaret Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
All
Age
0 to 8 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026