Nasal Prep for Nasendoscopy in Children

Phase 4

Completed

• Conditions: Flexible Nasendoscopy
• Interventions: Drug: Isotonic normal saline; Drug: 0.05% xylometazoline hydrochloride; Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride

• Registration Number: NCT01351298
• Lead Sponsor: Children's & Women's Health Centre of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline spray	Isotonic normal saline	-
Decongestant	0.05% xylometazoline hydrochloride	-
Decongestant and local anesthetic	0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Pain score (self)	Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)	Self-reported Wong-Baker Faces Pain Score

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada