Throat DisorderPhase 4NCT03620513
Pretreatment to Reduce Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy
A Phase 4 study testing Decongestant (oxymetazoline 0.05%), Anesthesia (Lidocaine 15%) and Decongestants and Anesthesia (oxymetazoline and lidocaine) in people with Throat Disorder, run by Lumbini Medical College at 1 site in Nepal.
Trial summary
Fiberoptic laryngoscopy (FOL) is one of the most common procedure done in an Ear Nose Throat (ENT) clinic. Topical anesthesia or decongestant or both have been used to improve patient comfort level during the procedure. Recently, role of these agents has been questioned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Throat Disorder
- What is being tested?
- Decongestant (oxymetazoline 0.05%), Anesthesia (Lidocaine 15%) and Decongestants and Anesthesia (oxymetazoline and lidocaine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2018to 16 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing fiberoptic naso pharyngo laryngoscopy in OPD setting
- Consent to study
- above 18 years
Who cannot join
- gross nasal mass
- pregnants
- known hypersensitivity to the drugs used for premedication
- who cannot respond to questionnaire during data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study
Fiberoptic laryngoscopy (FOL) is one of the most common procedure done in an Ear Nose Throat (ENT) clinic. Topical anesthesia or decongestant or both have been used to improve patient comfort level during the procedure. Recently, role of these agents has been questioned. The investigators would like to study whether topical anesthesia or decongestant or their combination provide any benefit to the patients undergoing FOL.
Read the detailed description
Patient undergoing Fiberoptic laryngoscopy (FOL) will be randomized into four groups by block randomization. Group one will receive atomized spray of normal saline as placebo before the procedure. Group two will receive two sprays of atomized oxymetazoline (approx 0.18 ml of 0.05% oxymetazoline) with a gap of 10 seconds in between the sprays. Group three will receive two sprays of 15% lidocaine with a gap of 10 seconds in between the sprays. Group four will receive two sprays of oxymetazoline and then two sprays of lidocaine at an interval of two minutes.
Sample size calculation: With alpha error of 0.05, power of .8, mean discomfort scale for placebo of 2.8 (literature review) and SD of 1.1, presuming that the treatment would be able to reduce discomfort by at least 25%, with two tailed test and same SD, minimum sample size would be 40 in each group.
To reduce bias, all the procedure will be performed by senior consultants. Patients and the person performing the procedure will be blinded.
Discomfort of pre-medication, discomfort of scope insertion, pain due to scope insertion, and ease of procedure will be scored as VAS score (1 to 10, 1 is least and 10 is most). Also, patient will be asked how likely s/he is to recommend the similar procedure to his/her friends and family members in case they need to undergo the same. Side effects of pre-medication and procedure will also be noted.
Outcome variables among the groups will be compared using ANOVA test if they are normally distributed.
- Conditions
- Throat Disorder
- Being tested
- Decongestant (oxymetazoline 0.05%), Anesthesia (Lidocaine 15%), Decongestants and Anesthesia (oxymetazoline and lidocaine), Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decongestant (oxymetazoline 0.05%)Drug
Also called Nasivion
As described in arm/group
Anesthesia (Lidocaine 15%)Drug
Also called Nummit
As described in arm/group
Decongestants and Anesthesia (oxymetazoline and lidocaine)Drug
Also called Nasivion and Nummit
As described in arm/group
Normal salineDrug
Spray of normal saline as premedication
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline nasal spray | Placebo comparator | Two spray (via atomizer) of normal saline in each nostril five minutes prior to fiberoptic procedure Receives: Drug: Normal saline |
| Decongestant (Oxymetazoline 0.05%) | Experimental | Two sprays via atomizer (about 0.18 ml) of oxymetazoline 0.05% (Nasivion) in each nasal cavity five minutes prior to fiberoptic procedure. Two sprays will be given at the gap of ten seconds. Receives: Drug: Decongestant (oxymetazoline 0.05%) |
| Anesthesia (lidocaine 15%, Nummit) | Experimental | Two sprays of 15% lidocaine (Nummit) will be give in each nasal cavity five minutes prior to fiber optic procedure. Two sprays will be given at the gap of ten seconds. Receives: Drug: Anesthesia (Lidocaine 15%) |
| Decongestant and Anesthesia | Experimental | In this group decongestants and anesthesia (oxymetazoline and lidocaine) sprays will be used. Decongestant (Oxymetazoline 0.05%) will be give as described above. After two minutes, lidocaine 15% (Nummit) spray will be given as described above. Procedure will be done after five minutes of decongestant. Receives: Drug: Decongestants and Anesthesia (oxymetazoline and lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10
Discomfort will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Measured: At the end of the procedure
Secondary outcomes (6)
Discomfort of pre-treatment as VAS 1-10
Discomfort will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Measured: four minutes from the first spray
Prevalence of adverse effects of pre-medication
allergy, burning pain, altered taste, chocking sensation, headache will be asked and recorded
Measured: four minutes from the first spray
Pain due to procedure as VAS 1-10
Pain will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Measured: At the end of the procedure
Ease of procedure as VAS 1-10
Ease will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Measured: At the end of the procedure
Prevalence of adverse effects of procedure
bleeding, gag, nausea, vomiting will be noted
Measured: At the end of the procedure
Likely to recommend (not likely, can not say, very likely)
Patient will be asked, "How likely you are to recommend this procedure to your relative in case they are advised to". It will be scored as 1-Not at all; 2-not sure; 3-Strongly recommend
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Sep 2018
- Primary completion16 Jan 2019
- Study completion16 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Throat DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four arms of study group with equal number of subjects in each group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumbini Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anup Acharya, MS, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620513
- Sponsor's protocol ID
- 142
- Status last verified
- Mar 2020
- First submitted
- 8 Jul 2018
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data via journal website or on request to the researcher
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study
- ClinicalTrials.gov ID
- NCT03620513
- Acronym / sponsor ID
- 142
- Conditions
- Throat Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Lumbini Medical CollegeUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- 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.
Fiberoptic laryngoscopy (FOL) is one of the most common procedure done in an Ear Nose Throat (ENT) clinic. Topical anesthesia or decongestant or both have been used to improve patient comfort level during the procedure. Recently, role of these agents has been questioned. The investigators would like to study whether topical anesthesia or decongestant or their combination provide any benefit to the patients undergoing FOL.
Detailed description
Patient undergoing Fiberoptic laryngoscopy (FOL) will be randomized into four groups by block randomization. Group one will receive atomized spray of normal saline as placebo before the procedure. Group two will receive two sprays of atomized oxymetazoline (approx 0.18 ml of 0.05% oxymetazoline) with a gap of 10 seconds in between the sprays. Group three will receive two sprays of 15% lidocaine with a gap of 10 seconds in between the sprays. Group four will receive two sprays of oxymetazoline and then two sprays of lidocaine at an interval of two minutes.
Sample size calculation: With alpha error of 0.05, power of .8, mean discomfort scale for placebo of 2.8 (literature review) and SD of 1.1, presuming that the treatment would be able to reduce discomfort by at least 25%, with two tailed test and same SD, minimum sample size would be 40 in each group.
To reduce bias, all the procedure will be performed by senior consultants. Patients and the person performing the procedure will be blinded.
Discomfort of pre-medication, discomfort of scope insertion, pain due to scope insertion, and ease of procedure will be scored as VAS score (1 to 10, 1 is least and 10 is most). Also, patient will be asked how likely s/he is to recommend the similar procedure to his/her friends and family members in case they need to undergo the same. Side effects of pre-medication and procedure will also be noted.
Outcome variables among the groups will be compared using ANOVA test if they are normally distributed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Four arms of study group with equal number of subjects in each group
| Arm | Type | Receives |
|---|---|---|
| Normal Saline nasal spray | Placebo comparator | Drug: Normal salineTwo spray (via atomizer) of normal saline in each nostril five minutes prior to fiberoptic procedure |
| Decongestant (Oxymetazoline 0.05%) | Experimental | Drug: Decongestant (oxymetazoline 0.05%)Two sprays via atomizer (about 0.18 ml) of oxymetazoline 0.05% (Nasivion) in each nasal cavity five minutes prior to fiberoptic procedure. Two sprays will be given at the gap of ten seconds. |
| Anesthesia (lidocaine 15%, Nummit) | Experimental | Drug: Anesthesia (Lidocaine 15%)Two sprays of 15% lidocaine (Nummit) will be give in each nasal cavity five minutes prior to fiber optic procedure. Two sprays will be given at the gap of ten seconds. |
| Decongestant and Anesthesia | Experimental | Drug: Decongestants and Anesthesia (oxymetazoline and lidocaine)In this group decongestants and anesthesia (oxymetazoline and lidocaine) sprays will be used. Decongestant (Oxymetazoline 0.05%) will be give as described above. After two minutes, lidocaine 15% (Nummit) spray will be given as described above. Procedure will be done after five minutes of decongestant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing fiberoptic naso pharyngo laryngoscopy in OPD setting
- Consent to study
- above 18 years
Key exclusion criteria (4 listed)
- gross nasal mass
- pregnants
- known hypersensitivity to the drugs used for premedication
- who cannot respond to questionnaire during data collection
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 |
|---|---|---|
| Decongestant (oxymetazoline 0.05%)Also: NasivionAs described in arm/group | Drug | Decongestant (Oxymetazoline 0.05%) |
| Anesthesia (Lidocaine 15%)Also: NummitAs described in arm/group | Drug | Anesthesia (lidocaine 15%, Nummit) |
| Decongestants and Anesthesia (oxymetazoline and lidocaine)Also: Nasivion and NummitAs described in arm/group | Drug | Decongestant and Anesthesia |
| Normal salineSpray of normal saline as premedication | Drug | Normal Saline nasal spray |
Primary outcome
Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10
Time frame: At the end of the procedure
Discomfort will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
6 secondary outcomes
Discomfort of pre-treatment as VAS 1-10
Time frame: four minutes from the first spray
Prevalence of adverse effects of pre-medication
Time frame: four minutes from the first spray
Pain due to procedure as VAS 1-10
Time frame: At the end of the procedure
Ease of procedure as VAS 1-10
Time frame: At the end of the procedure
Prevalence of adverse effects of procedure
Time frame: At the end of the procedure
Likely to recommend (not likely, can not say, very likely)
Time frame: At the end of the procedure
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 9 Mar 2020.
- Individual participant dataSharing planned: Yes. Anonymized data via journal website or on request to the researcher
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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.
Anup Acharya, MS principal investigator
Associate Professor
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 Decongestant (oxymetazoline 0.05%), Anesthesia (Lidocaine 15%) and Decongestants and Anesthesia (oxymetazoline and lidocaine) in people with Throat Disorder, run by Lumbini Medical College at 1 site in Nepal.
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: finished, as of the sponsor's last update on 9 Mar 2020. 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 Nepal. 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?
Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10 (time frame: At the end of the procedure). 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 9 Mar 2020.