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Intra-nasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: a Randomised Double-blind Placebo Controlled Trial
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.
Details
| Lead sponsor | Children's & Women's Health Centre of British Columbia |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 69 |
| Start date | 2011-06 |
| Completion | 2012-06 |
Conditions
- Flexible Nasendoscopy
Interventions
- 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride
- 0.05% xylometazoline hydrochloride
- Isotonic normal saline
Primary outcomes
- Pain score (self) — Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)
Self-reported Wong-Baker Faces Pain Score
Countries
Canada