NCT07000877

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

Nasal Decongestant Administration to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having General Anesthesia - a Low Risk Intervention. (NARWHAL)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Telethon Kids Institute · Academic / Other
• Sex: All
• Age: 1 Year – 8 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Upper respiratory tract infections (URTI), including COVID-19 infection and the common cold, are common and frequent in children who present for elective surgery. Children with URTI are at a two-to-three-fold increased risk of perioperative respiratory adverse events (PRAE). PRAE are among the most serious and impactful consequences of paediatric anesthesia, including cardio-respiratory arrest, and therefore present a significant challenge for the pediatric anesthetist. This two-phase, multicentre, international, double-blinded, randomised controlled trial aims to improve the safety of children with upper respiratory tract infections undergoing anesthesia by investigating the use of a nasal spray pre-operatively to reduce respiratory complications. Following informed written parental consent, 200 pediatric patients aged 1 to 8 years, undergoing general anesthesia for any surgery with current or recent URTI will be randomised to receive at the induction of anesthesia either a decongestant nasal spray or a placebo spray using the same bottle/actuator. Monitoring and recording of PRAE (laryngospasm - closure of the vocal cords, bronchospasm - narrowing of the airways, severe and persistent coughing, airway obstruction, oxygen desaturation (\<95%) and postoperative stridor-squeaky noises when breathing) will occur throughout the procedure and in the post anesthesia care unit (PACU). We hypothesise that children who receive the nasal decongestant will be at a reduced risk of developing PRAE.

Conditions

• Perioperative Respiratory Adverse Events
• Anesthesia Outcomes

Interventions

Type	Name	Description
DRUG	Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))	Decongestant nasal spray containing active ingredient.
DRUG	PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%	Control nasal spray containing no active ingredient.

Timeline

• Start date: 2025-06-25
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2025-06-03
• Last updated: 2025-11-19

Locations

1 site across 1 country: Australia