None listed
Conditions
Brief summary
The use of general anaesthesia (GA) in infants and young children has generally been considered safe. Recent research from laboratory animal studies has raised concerns that exposure to anaesthetic medicines in early life could potentially be related to impaired memory, learning and behaviour. Cystic Fibrosis (CF) is an inherited condition that is usually diagnosed in the first few weeks of life through the newborn screening program. CF leads to serious chest infections and lung damage. To try and identify chest infections and treat them early before they have a chance to cause lung damage, children with CF may undergo many tests and treatments. The ACFBAL study was initiated to examine the use of BAL to direct therapy in young children with CF who are unable to expectorate sputum. This current study takes advantage of the previous randomisation to bronchoscopy directed therapy where children received bronchoscopy and BAL at baseline initially in the first six months of life, and subsequently with exacerbations requiring hospital admission or with Pseudomonas aeruginosa identified from oropharyngeal sampling.
Interventions
Children with cystic fibrosis with exposure to general anaesthesia (GA) in the first 2 years of life.
Children who were randomised to the bronchoalveolar lavage (BAL) treatment arm of the ACFBAL Study (ACTRN12605000665639) had baseline BAL under GA at a median age of 144 days. Following the baseline BAL, further bronchoscopies were performed in children in the BAL arm with hospitalisation for intravenous antibiotics if Pseudomonas aeruginosa was cultured from oropharyngeal specimens, and follo
Children with cystic fibrosis with exposure to general anaesthesia (GA) in the first 2 years of life. Children who were randomised to the bronchoalveolar lavage (BAL) treatment arm of the ACFBAL Study (ACTRN12605000665639) had baseline BAL under GA at a median age of 144 days. Following the baseline BAL, further bronchoscopies were performed in children in the BAL arm with hospitalisation for intravenous antibiotics if Pseudomonas aeruginosa was cultured from oropharyngeal specimens, and following completion of Pseudomonas aeruginosa eradication therapy. Thus, the total number of GA exposures for the BAL arm was different for each participant depending on clinical presentation. The protocol for GA included no premedication. 100% oxygen with sevoflurane up to 8% was used for induction of anaesthesia. Atropine was administered 5mcg/kg and lignocaine 1% sprayed onto the vocal cords to a max of 3mg/kg. A laryngeal mask was placed when adequate depth of anaesthesia was achieved. 100% oxygen with sevoflurane up to 8% was given and adjusted to allow spontaneous breathing. Propofol use was accepted at the discretion of the anaesthetist and if required 0.5mg/kg was given in incremental boluses or run by continuous infusion. If coughing was a significant problem, muscle relaxants could be administered with full reversal at the end of the procedure.
Sponsors
Department of Health and Ageing
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
9 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Children will be eligible for this study if they received no general anaesthesia prior to randomisation for the ACFBAL study. ACTRN12605000665639 Wainwright CE, Vidmar S, Armstrong DS, et al. Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: a randomized trial. Jama 2011;306:163-71.
Exclusion criteria
Children will not be eligible for this study if they received general anaesthesia prior to randomisation for the ACFBAL study or if they were diagnosed with a condition that affects neurobehavioural testing prior to randomisation for the ACFBAL Study.
Outcome results
None listed