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

Study acronym: NARWHAL
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 30, 2025 to Jun 25, 2025
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07000877
Lead Sponsor Telethon Kids Institute
Collaborators: Child and Adolescent Health Service - Perth, University of Sao Paulo General Hospital, Rigshospitalet, Denmark
Conditions
(from sponsor)
Perioperative Respiratory Adverse Events, Anesthesia Outcomes
Related terms Respiratory Tract Infections
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov