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OpenTrials
Completed

NCT Number: NCT01351298

Nasal Prep for Nasendoscopy in Children

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.

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Key information

Conditions

Flexible Nasendoscopy

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

BC Children's Hospital

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride

Drug

Decongestant with local anesthetic

0.05% xylometazoline hydrochloride

Drug

Decongestant

Isotonic normal saline

Drug

Placebo

Primary outcomes

  1. Pain score (self)

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

    Self-reported Wong-Baker Faces Pain Score

Secondary outcomes

  1. Pain score (proxy)

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

    The caregiver-proxy Wong-Baker Faces Pain Score

  2. Ease of nasendoscopy score

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

    Visual analog scale endoscopist rating

Sponsors and collaborators

Lead sponsor

Children's & Women's Health Centre of British Columbia

Other

Registry information

Official study title

Intra-nasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: a Randomised Double-blind Placebo Controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2011
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.