Flexible NasendoscopyPhase 4NCT01351298
Nasal Prep for Nasendoscopy in Children
A Phase 4 study testing 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride, 0.05% xylometazoline hydrochloride and Isotonic normal saline in people with Flexible Nasendoscopy, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Flexible Nasendoscopy
- What is being tested?
- 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride, 0.05% xylometazoline hydrochloride and Isotonic normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intra-nasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: a Randomised Double-blind Placebo Controlled Trial
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.
- Conditions
- Flexible Nasendoscopy
- Being tested
- 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride, 0.05% xylometazoline hydrochloride, Isotonic normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% xylometazoline hydrochloride with 1% lidocaine hydrochlorideDrug
Decongestant with local anesthetic
0.05% xylometazoline hydrochlorideDrug
Decongestant
Isotonic normal salineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Saline spray | Placebo comparator | Not described Receives: Drug: Isotonic normal saline |
| Decongestant | Experimental | Not described Receives: Drug: 0.05% xylometazoline hydrochloride |
| Decongestant and local anesthetic | Experimental | Not described Receives: Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (self)
Self-reported Wong-Baker Faces Pain Score
Measured: Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)
Secondary outcomes (2)
Pain score (proxy)
The caregiver-proxy Wong-Baker Faces Pain Score
Measured: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
Ease of nasendoscopy score
Visual analog scale endoscopist rating
Measured: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Flexible NasendoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's & Women's Health Centre of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Chadha, Children's & Women's Health Centre of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351298
- Sponsor's protocol ID
- H11-00602
- Status last verified
- Dec 2012
- First submitted
- 6 May 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24158493
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-nasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: a Randomised Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01351298
- Acronym / sponsor ID
- H11-00602
- Conditions
- Flexible Nasendoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Children's & Women's Health Centre of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline spray | Placebo comparator | Drug: Isotonic normal saline |
| Decongestant | Experimental | Drug: 0.05% xylometazoline hydrochloride |
| Decongestant and local anesthetic | Experimental | Drug: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Children who have previously undergone this procedure
- Children with current upper respiratory tract infection
- Children with known allergy to any of the trial medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochlorideDecongestant with local anesthetic | Drug | Decongestant and local anesthetic |
| 0.05% xylometazoline hydrochlorideDecongestant | Drug | Decongestant |
| Isotonic normal salinePlacebo | Drug | Saline spray |
Primary outcome
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
2 secondary outcomes
Pain score (proxy)
Time frame: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
Ease of nasendoscopy score
Time frame: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Derived from this study: PubMed 24158493Chadha 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride, 0.05% xylometazoline hydrochloride and Isotonic normal saline in people with Flexible Nasendoscopy, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (self) (time frame: Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.