Nasal Prep for Nasendoscopy in Children

Sponsor

Children's & Women's Health Centre of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01351298

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Flexible Nasendoscopy	Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride Drug: 0.05% xylometazoline hydrochloride Drug: Isotonic normal saline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BC Children's Hospital	Vancouver	British Columbia	Canada

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neil Chadha, Clinical Assistant Professor, Children's & Women's Health Centre of British Columbia

ClinicalTrials.gov Identifier:

NCT01351298

Other Study ID Numbers:

H11-00602

First Posted:

May 10, 2011

Last Update Posted:

Dec 6, 2012

Last Verified:

Dec 1, 2012

Additional relevant MeSH terms:

Lidocaine

Xylometazoline

Study Results

No Results Posted as of Dec 6, 2012