Flexible Nasendoscopy
Conditions
Brief summary
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.
Interventions
DRUG0.05% xylometazoline hydrochloride
Decongestant
DRUGIsotonic normal saline
Placebo
DRUG0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride
Decongestant with local anesthetic
Sponsors
Children's & Women's Health Centre of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score (self) | Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1) | Self-reported Wong-Baker Faces Pain Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score (proxy) | Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) | The caregiver-proxy Wong-Baker Faces Pain Score |
| Ease of nasendoscopy score | Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) | Visual analog scale endoscopist rating |
Countries
Canada
Outcome results
None listed