None listed
Conditions
Brief summary
Despite the development of anaesthesia management guidelines, perioperative respiratory adverse events (PRAE) remain a major cause of morbidity and mortality during paediatric anaesthesia, causing more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. In a previous large cohort study in over 9000 children, we identified several risk factors (current or recent upper respiratory tract infection, wheezing >3 times in the last 12 months, eczema, nocturnal dry cough, a family history of asthma, eczema, rhinitis or passive smoking) which can help in every day clinical practice to identify the children at a particularly high risk for PRAE. Additionally, we demonstrated in an audit of children with a recent URTI, that inhaled salbutamol reduced the incidence of perioperative bronchospasm (5% vs. 11%, p=0.027) and persistent coughing (5.5% vs. 11.5%, p=0.0314) in the perioperative period. The role of pre-treatment with reliever medications for other PRAE risk factors (such as asthma, present/past eczema) is unknown. We therefore propose a double blinded randomised controlled trial of the use of inhaled salbutamol in children with two or more known risk factors for PRAE on the incidence of PRAE. We will randomise 470 children (6-16 years) to receive either inhaled salbutamol or an inhaled placebo prior to the administration of anaesthesia. We will also assess lung function before and 15 minutes after the administration of salbutamol or placebo. Furthermore, we will monitor and record all respiratory complications (laryngospasm, bronchospasm, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor). We hypothesise that children receiving salbutamol will experience significantly less PRAE when compared with children who did not receive salbutamol preoperatively. This study may help to reduce the health costs associated with respiratory complications (e.g. unplanned hospital admissions, prolonged hospital stay, additional treatment) and may help us to avoid unexpected admissions to the intensive care unit. Additionally, our findings may lead to a reduction in waiting list times and aid us in deciding the best time for the child’s surgery. Finally, this study may increase the availability of preventative strategies that may reduce the numbers of children who have their surgery cancelled due to respiratory issues. Cancellation of surgery has an adverse economic impact for hospitals, causes enormous emotional and financial burdens on the child and his/her family who have made many arrangements to attend hospital. Reducing the number of cancellations will ease the distress experienced by children and their parents when surgery does not go ahead as planned, which will have add on effects for child/parent satisfaction regarding their hospital experience.
Interventions
All participants will be recruited at the pre-anaesthetic visit and randomised to receive either an inhaled placebo or inhaled salbutamol (200 mg; Ventolin, GSK) via a Metered Dose Inhaler (pMDI) and spacer approx 30 min prior to surgery. The attending anaesthetists, the surgeon, recovery staff, as well as the research staff undertaking lung function assessments will be blinded to the group allocation.
Sponsors
Princess Margaret Hospital for Children
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Children, aged 6-16 years, male or female, undergoing elective surgery with a laryngeal mask airway. All children have to have 2 or more risk factors for respiratory complications: 1) Upper respiratory tract infection < 2 weeks prior to surgery 2) eczema at present or in the past 3) wheezing in the last 12 months 4) previous asthma (if wheezing in the past year is negative) 5) dry night cough 6) respiratory symptoms with exercise 7) family history of asthma (mother, father and/or siblings) 8) family history of eczema (mother, father and/or siblings) 9) family history of hayfever(mother, father and/or siblings) 10) passive smoke exposure (mother, father, caregiver)
Exclusion criteria
Known cardiac disease, airway or thoracic malformations, syndrome, neurological disorder, need for premedication, contraindication for LMA use as assessed by an anaesthetist independent of the study team. Any surgery involving the upper airway, chest or abdomen.
Outcome results
None listed