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Nasal Prep for Nasendoscopy in Children

Information source: Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Flexible Nasendoscopy

Intervention: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride (Drug); 0.05% xylometazoline hydrochloride (Drug); Isotonic normal saline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Children's & Women's Health Centre of British Columbia

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain score (self)

Secondary outcome:

Pain score (proxy)

Ease of nasendoscopy score

Eligibility

Minimum age: 3 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

BC Children's Hospital, Vancouver, British Columbia, Canada
Additional Information

Starting date: June 2011
Last updated: December 4, 2012

Page last updated: August 20, 2015

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