Nasal Prep for Nasendoscopy in Children

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

Status and phase: Completed; Phase 4

Conditions: Flexible Nasendoscopy

Treatments: Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride; Drug: Isotonic normal saline; Drug: 0.05% xylometazoline hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01351298

H11-00602

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 3 patient groups, including a placebo group

Saline spray

Placebo Comparator group

Treatment:

Drug: Isotonic normal saline

Decongestant

Experimental group

Treatment:

Drug: 0.05% xylometazoline hydrochloride

Decongestant and local anesthetic

Experimental group

Treatment:

Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride