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Nasal Prep for Nasendoscopy in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neil Chadha, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier:
NCT01351298
First received: May 6, 2011
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Flexible Nasendoscopy
 Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride
Drug: 0.05% xylometazoline hydrochloride
Drug: Isotonic normal saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:
  • Pain score (self) [ Time Frame: Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1) ] [ Designated as safety issue: No ]
    Self-reported Wong-Baker Faces Pain Score


Secondary Outcome Measures:
  • Pain score (proxy) [ Time Frame: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) ] [ Designated as safety issue: No ]
    The caregiver-proxy Wong-Baker Faces Pain Score

  • Ease of nasendoscopy score [ Time Frame: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) ] [ Designated as safety issue: No ]
    Visual analog scale endoscopist rating


Enrollment: 69
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351298

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
  More Information

No publications provided

Responsible Party: Neil Chadha, Clinical Assistant Professor, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT01351298     History of Changes
Other Study ID Numbers: H11-00602
Study First Received: May 6, 2011
Last Updated: December 4, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Anesthetics, Local
Lidocaine
Anesthetics
Ephedrine
Oxymetazoline
Phenylephrine
Xylometazoline
Pseudoephedrine
Nasal Decongestants
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
 Therapeutic Uses
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists

ClinicalTrials.gov processed this record on May 21, 2013