The goal of this multicentre, double-blind, randomised controlled trial study is to learn if the use of a nasal spray to open the nasal passages and increase airflow before surgery can reduce the occurrence of perioperative respiratory adverse events in children with upper respiratory tract infection who are undergoing anesthesia.
The main questions it aims to answer are:
* Does use of a nasal decongestant (Oxymetazoline 0.05%) reduce perioperative respiratory adverse events during emergence (when waking up from anesthesia) or in the post-anesthesia care unit in children. * Is it easy and acceptable to doctors, children and parents to use the nasal decongestant treatment? Researchers will compare the nasal decongestant to a placebo (a look-alike substance that contains no drug) to see if it works to reduce perioperative respiratory adverse effects.
Participants will:
* Take a nasal decongestant or a placebo prior to surgery (just before anaesthesia is given) * Be monitored during and after surgery in the post-anaesthesia care unit for any perioperative respiratory adverse events. * Be asked about how acceptable they found the treatment.
Children aged 1 to 8.99 years with a current or recent upper respiratory tract infection (<2 weeks).
Undergoing interventions or surgery under general anesthesia (elective or urgent not emergency).
Currently taking nasal decongestants (past 24 hours) or receiving co-phenylocaine or decongestion for surgery.
Surgery impacting the nasal airflow, e.g. adenoidectomy, cautery of inferior turbinates.
Airway management with an endotracheal tube, face mask or high flow nasal oxygen.
Known cardiovascular, respiratory or neurological disorders giving an ASA III or above.
Parallel
Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))
DrugDecongestant nasal spray containing active ingredient.
PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%
DrugControl nasal spray containing no active ingredient.
Incidence of perioperative respiratory adverse event (PRAE) following the delivery of a nasal decongestant (Oxymetazoline 0.05%) or placebo prior to surgery under anesthesia in children with upper respiratory tract infection
PRAE will be defined as laryngospasm, bronchospasm, severe persistant coughing, hypoxaemia (\<95% for at least 10 seconds), airway obstruction, stridor or pulmonary aspiration. Incidence will be assessed by the clinician caring for the patient. Incidence is binary - yes if PRAE occured, no otherwise.
Assess the incidence of severe PRAE during emergence or in PACU in children who received the decongestant spray compared to the control group.
Severe PRAE is defined as laryngospasm or bronchospasm, as assessed by the clinician caring for the patient.
Assess the incidence of minor PRAE during emergence or in PACU inchildren who recieved the decongestant spray compared to the control group.
Minor PRAE is defined as severe coughing, desaturation \<95% for at least 10 seconds, airway obstruction, stridor or pulmonary aspiration, as assessed by the clinician caring for the patient.
Evaluate the acceptability of nasal decongestant use at the induction of anesthesia in children with upper respiratory tract infection aged 4 and older and their parents/guardians
Children aged 4 and over and their parents/guardians will be asked to rate the acceptibility of the intervention using a 5-point Likert scale (1 = completely unacceptable; 5 = completely acceptable).
Evaluate the acceptability of nasal decongestant use at the induction of anesthesia by the treating anaesthetist
Treating anaesthetists will be asked to rate the acceptibility of the intervention on a 5-point Likert scale (1 = completely unacceptable; 5 = completely acceptable)
Click on the lead sponsor to view all of their trials.
Telethon Kids Institute
Lead sponsor
Child and Adolescent Health Service - Perth
Collaborator
Hospital das Clínicas de São Paulo - SP
Collaborator
Rigshospitalet, Denmark
Collaborator
