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| Name | Class |
|---|---|
| Child and Adolescent Health Service - Perth | OTHER_GOV |
| University of Sao Paulo General Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decongestant nasal spray (oxymetazoline hydrochloride 0.05%) | Active Comparator | Decongestant nasal spray, oxymetazoline (0.05%). Specific: 2.5mL of oxymetazoline 0.05% dispensed into amber brown 15ml bottles with pump and actuator attached. Children aged 1 to 5.99 years will receive 1 spray of either the nasal decongestant or placebo into each nostril, while children aged 6 years and above will receive 2 spays per nostril. Administration will be recorded on the standard patient's Medication Chart. |
|
| Placebo Comparator : Placebo spray (control group) | Placebo Comparator | Matched Placebo spray. Specific: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02% dispensed into amber brown 15ml bottles with pump and actuator attached. Dose: children aged 1 to 5.99 years will receive 1 spray of either the nasal decongestant or placebo into each nostril, while children aged 6 years and above will receive 2 spays per nostril. Administration will be recorded on the standard patient's Medication Chart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decongestant nasal spray (oxymetazoline hydrochloride (0.05%)) | Drug | Decongestant nasal spray containing active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery: Perioperative period. Severe 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Britta S. von Ungern-Sternberg, MD PHD | Contact | +618 6456 4806 | britta.regli-vonungern@health.wa.gov.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perth Children's Hospital | Recruiting | Perth | We | Australia |
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Multicentre, double-blinded randomised controlled trial
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Double Blind trial
| PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02% | Drug | Control nasal spray containing no active ingredient. |
|
| 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. | Day of surgery: Perioperative period. Minor 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) |
| 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). | Patients and parents/guardians will be asked to rate the intervention post-operatively, prior to their discharge from hospital. |
| 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) | Treating anaesthetists will be asked to rate the intervention immediately after the administration of the interventional product. |
| Incidence of any potential adverse effects related to the administration of the nasal decongestant/placebo | Any potential adverse effects will be recorded as per the study doctor and the clinical team caring for the patient. | Any potential adverse effects will be assessed from the administration of the interventional product until the patient's discharge from hospital. |
| Assessment of the successful administration of the interventional product in children | This will be based upon the clinical judgement of the treating anesthesia clinician. | Successful administration of the interventional product will be assessed by the study team at induction of anesthesia, immediately following the administration or attempted administration of the nasal decongestant or placebo. |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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