Nasal Prep for Nasendoscopy in Children

Study Overview
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Brief Summary
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Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in outpatients. The purpose of this randomized controlled double-blind study is to determine whether there is a difference in the degree of discomfort experienced by children undergoing flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C) decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride). Null hypothesis: There is no difference in the degree of reported discomfort experienced (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after receiving either intra-nasal topical placebo, decongestant, or decongestant with local anesthetic.

Official Title
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Intra-nasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: a Randomised Double-blind Placebo Controlled Trial

Conditions
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Flexible Nasendoscopy

Intervention / Treatment
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* Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride
* Drug: 0.05% xylometazoline hydrochloride
* Drug: Isotonic normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fully informed consent from parent/caregiver Children aged 3 to 12 years Children deemed to require flexible nasendoscopy as part of their assessment during a Pediatric Otolaryngology clinic visit Exclusion Criteria: Children who have previously undergone this procedure Children with current upper respiratory tract infection Children with known allergy to any of the trial medications

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline spray<br> | Drug: Isotonic normal saline<br>* Placebo<br>|
| Experimental: Decongestant<br> | Drug: 0.05% xylometazoline hydrochloride<br>* Decongestant<br>|
| Experimental: Decongestant and local anesthetic<br> | Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride<br>* Decongestant with local anesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (self) | Self-reported Wong-Baker Faces Pain Score | Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (proxy) | The caregiver-proxy Wong-Baker Faces Pain Score | Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) | 
| Ease of nasendoscopy score | Visual analog scale endoscopist rating | Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) |