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Nasal Prep for Nasendoscopy in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351298
First Posted: May 10, 2011
Last Update Posted: December 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neil Chadha, Children's & Women's Health Centre of British Columbia
  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
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

Further study details as provided by Neil Chadha, 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) ]
    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) ]
    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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: May 6, 2011
First Posted: May 10, 2011
Last Update Posted: December 6, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Ephedrine
Pseudoephedrine
Nasal Decongestants
Xylometazoline
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Respiratory System Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Adrenergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Anti-Asthmatic Agents