Nasal Prep for Nasendoscopy in Children

NCT01351298 | Completed Phase 4

• 1 other identifier: H11-00602
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexible Nasendoscopy

Outcome Measures

Primary Outcomes (1)

• Pain score (self)

  Self-reported Wong-Baker Faces Pain Score

  Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)

Secondary Outcomes (2)

• Pain score (proxy)

  Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)

• Ease of nasendoscopy score

  Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)

Study Arms (3)

Saline spray

PLACEBO COMPARATOR

Drug: Isotonic normal saline

Decongestant

EXPERIMENTAL

Drug: 0.05% xylometazoline hydrochloride

Decongestant and local anesthetic

EXPERIMENTAL

Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride

Interventions

0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride DRUG

Decongestant with local anesthetic

Decongestant and local anesthetic

0.05% xylometazoline hydrochloride DRUG

Decongestant

Decongestant

Isotonic normal saline DRUG

Placebo

Saline spray

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children who have previously undergone this procedure
• Children with current upper respiratory tract infection
• Children with known allergy to any of the trial medications

Sponsors & Collaborators

• Children's & Women's Health Centre of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Chadha NK, Lam GO, Ludemann JP, Kozak FK. Intranasal topical local anesthetic and decongestant for flexible nasendoscopy in children: a randomized, double-blind, placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 Dec;139(12):1301-5. doi: 10.1001/jamaoto.2013.5297.

  PMID: 24158493 DERIVED

MeSH Terms

Interventions

xylometazoline; Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 10, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

CA (1)