Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.

Condition(s) studied

Investigational drug(s) / intervention(s)

Decongestant nasal spray (oxymetazoline hydrochloride (0.05%)): Decongestant nasal spray containing active ingredient.

PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%: Control nasal spray containing no active ingredient.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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 — On day of surgery: Perioperative period. PRAE will be assessed if it occurs anywhere along the perioperative pathway between the beginning of the patient's emergence from anesthesia and their discharge from the post-anesthetic care unit (PACU)
  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.

Trial sites (1)

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