Reducing periOperative Adverse Respiratory events (ROAR) in children undergoing adenotonsillectomy who present with recurrent respiratory symptoms

Phase 4

• Conditions: Post-operative adverse respiratory events; Anaesthesiology - Other anaesthesiology; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12619000243112
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Study Completion: 2021-01-21
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 4 > Age < 10
• Male/Female
• Adenotonsilectomy +/- adenoidectomy, grommets, cautery of inferior turbinates, or examination of the ear under general anaesthesia with the use of laryngeal mask airway or endotracheal tubes
• Respiratory symptoms in the past 12 months including:
- wheeze
- shortness of breath
- 4 weeks cough
- exercise induced respiratory symptoms
• eNO measurement greater than or equal to 20 ppb

Exclusion Criteria

• 4 > Age > 10
• Cystic Fibrosis, bronchiectasis
• Significant cardiac disease
• Preventer asthma medications other than the study intervention in the last 3 months such as:
- Inhaled corticosteroids (other than the supplied study intervention e.g. budenoside, beclomethasone dipropionate, mometasone furoate, ciclesonide)
- Long-acting beta agonists (other than study intervention) or an extended release short-acting beta-agonist
- Leukotriene-receptor agonists (e.g. montelukast), theophylline, cromolyn, or other non-inhaled/oral corticosteroid asthma controller medications
• Prescription or over the counter medications that would significantly interact with beta-agonists or inhaled corticosteroids
• Potent Cytochrome P450 3A4 (CYP3A4) inhibitors within 4 weeks of Visit 1 and during the double-blind treatment period (e.g. clarithromycin, ritonavir, ketoconazole, itraconazole)
• Inhaled anti-cholinergics (e.g. tiotropium, ipratropium)
• Anti-IgE (e.g. Xolair [omalizumab])
• Other immunomodulators (e.g. azathioprine, cyclosporine, methotrexate)
• Anticonvulsants (barbiturates, hydantoins and carbamazepine)
• Polycyclic antidepressants
• beta-adrenergic blocking agents
• Phenothiazines
• Monoamine oxidase (MAO inhibitors)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of treatment (Fluticasone propionate 250mcg per day) on the number of respiratory complications in the perioperative period. <br>Respiratory complications may include:<br>• Laryngospasm<br>• Bronchospasm<br>• Oxygen desaturation:<br>• Severe persistent coughing<br>• Stridor<br>Perioperative respiratory adverse events (PRAE) outcomes will be recorded during surgery and the recovery period in the post-anesthesia care unit (PACU)<br>[Primary outcome assessed by PRAE outcomes during surgery and during the recovery period in PACU. ]