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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline spray | Placebo Comparator |
| |
| Decongestant | Experimental |
| |
| Decongestant and local anesthetic | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride | Drug | Decongestant with local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score (self) | Self-reported Wong-Baker Faces Pain Score | Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score (proxy) | The caregiver-proxy Wong-Baker Faces Pain Score | Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) |
| Ease of nasendoscopy score | Visual analog scale endoscopist rating |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital | Vancouver | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24158493 | Derived | 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. |
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| ID | Term |
|---|---|
| C009695 | xylometazoline |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 0.05% xylometazoline hydrochloride | Drug | Decongestant |
|
| Isotonic normal saline | Drug | Placebo |
|
| Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1) |
| Aniline Compounds |
| D000588 | Amines |