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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-8
SponsorTelethon Kids Institute

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))
  • PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Telethon Kids Institute

Lead sponsor

Child and Adolescent Health Service - Perth

Collaborator

Hospital das Clínicas de São Paulo - SP

Collaborator

Rigshospitalet, Denmark

Collaborator