Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
69 participants
INTERVENTIONAL
2011-06-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Saline spray
Isotonic normal saline
Placebo
Decongestant
0.05% xylometazoline hydrochloride
Decongestant
Decongestant and local anesthetic
0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride
Decongestant with local anesthetic
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride
Decongestant with local anesthetic
0.05% xylometazoline hydrochloride
Decongestant
Isotonic normal saline
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 with current upper respiratory tract infection
* Children with known allergy to any of the trial medications
3 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's & Women's Health Centre of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Neil Chadha
Clinical Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
BC Children's Hospital
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chadha NK, Lam GO, Ludemann JP, Kozak FK. Intranasal topical local anesthetic and decongestant for flexible nasendoscopy in children: a randomized, double-blind, placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 Dec;139(12):1301-5. doi: 10.1001/jamaoto.2013.5297.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H11-00602
Identifier Type: -
Identifier Source: org_study_id