Nasal Prep for Nasendoscopy in Children

December 4, 2012 updated by: Neil Chadha, Children's & Women's Health Centre of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline spray
Drug: Isotonic normal saline
Placebo
Experimental: Decongestant
Drug: 0.05% xylometazoline hydrochloride
Decongestant
Experimental: Decongestant and local anesthetic
Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride
Decongestant with local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
Ease of nasendoscopy score
Time Frame: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
Visual analog scale endoscopist rating
Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-00602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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