Overview

Nasal Prep for Nasendoscopy in Children

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's & Women's Health Centre of British Columbia
Treatments:
Anesthetics
Anesthetics, Local
Ephedrine
Lidocaine
Nasal Decongestants
Pseudoephedrine
Xylometazoline
Criteria
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