NasofibroscopyPhase 3NCT01125332
Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric Ear Nose Throat (ENT)Consultation
A Phase 3 study testing Indirect laryngoscopy in the flexible nasofibroscope in people with Nasofibroscopy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Nasofibroscopy
- What is being tested?
- Indirect laryngoscopy in the flexible nasofibroscope
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Nov 2010
- Phase
- Phase 3
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects from 4 to 7 years old (old enough to answer the test of self-assessment, the scale of faces)
- Appearing at the consultation of pediatric ENT, requiring an indirect laryngoscopy in the naso-fiberscope for a laryngeal evaluation.
- Subjects girls or boys
Who cannot join
- All the criteria dissuading the employment of a local anesthetic
- Naso-fibroscopie realized within the framework of a nasal obstruction, or of a balance sheet of the gulp.
- Patients having already been examined by naso-fiberscopy, so that their reactions and their answers are not influenced by the previous experience of the examination.
- Not consent of one of both holders of the parental authority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.
- Conditions
- Nasofibroscopy
- Being tested
- Indirect laryngoscopy in the flexible nasofibroscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect laryngoscopy in the flexible nasofibroscopeDrug
Indirect laryngoscopy in the flexible nasofibroscopeDrug
| Study group | Role | What they receive |
|---|---|---|
| group gel KY | Placebo comparator | Not described Receives: Drug: Indirect laryngoscopy in the flexible nasofibroscope |
| group gel lidocaine | Experimental | Not described Receives: Drug: Indirect laryngoscopy in the flexible nasofibroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacity of local anesthetic
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.
Secondary outcomes (1)
pain's scale
The child estimates his(her) own pain by postponing her(it) on a scale of more or less painful faces.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NasofibroscopyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RICHARD NICOLLAS, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125332
- Sponsor's protocol ID
- 2009 10
- Other IDs
- 2009-011010-23, 2009
- Status last verified
- Aug 2014
- First submitted
- 17 May 2010
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation
- ClinicalTrials.gov ID
- NCT01125332
- Acronym / sponsor ID
- 2009 10
- Conditions
- Nasofibroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 May 2010 (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.
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group gel KY | Placebo comparator | Drug: Indirect laryngoscopy in the flexible nasofibroscope |
| group gel lidocaine | Experimental | Drug: Indirect laryngoscopy in the flexible nasofibroscope |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects from 4 to 7 years old (old enough to answer the test of self-assessment, the scale of faces)
- Appearing at the consultation of pediatric ENT, requiring an indirect laryngoscopy in the naso-fiberscope for a laryngeal evaluation.
- Subjects girls or boys
Key exclusion criteria (4 listed)
- All the criteria dissuading the employment of a local anesthetic
- Naso-fibroscopie realized within the framework of a nasal obstruction, or of a balance sheet of the gulp.
- Patients having already been examined by naso-fiberscopy, so that their reactions and their answers are not influenced by the previous experience of the examination.
- Not consent of one of both holders of the parental authority
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 |
|---|---|---|
| Indirect laryngoscopy in the flexible nasofibroscope | Drug | group gel KY |
| Indirect laryngoscopy in the flexible nasofibroscope | Drug | group gel lidocaine |
Primary outcome
efficacity of local anesthetic
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.
1 secondary outcome
pain's scale
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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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.
RICHARD NICOLLAS principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indirect laryngoscopy in the flexible nasofibroscope in people with Nasofibroscopy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 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: stopped early, as of the sponsor's last update on 1 Sep 2014. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
efficacity of local anesthetic. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2014.