Pretreatment to Reduce Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study

Conditions
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Throat Disorder

Intervention / Treatment
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* Drug: Decongestant (oxymetazoline 0.05%)
* Drug: Anesthesia (Lidocaine 15%)
* Drug: Decongestants and Anesthesia (oxymetazoline and lidocaine)
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing fiberoptic naso pharyngo laryngoscopy in OPD setting Consent to study above 18 years Exclusion Criteria: gross nasal mass pregnants known hypersensitivity to the drugs used for premedication who cannot respond to questionnaire during data collection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Four arms of study group with equal number of subjects in each group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline nasal spray<br>Two spray (via atomizer) of normal saline in each nostril five minutes prior to fiberoptic procedure | Drug: Normal saline<br>* Spray of normal saline as premedication<br>|
| Experimental: Decongestant (Oxymetazoline 0.05%)<br>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. | Drug: Decongestant (oxymetazoline 0.05%)<br>* As described in arm/group<br>* Other names: Nasivion;|
| Experimental: Anesthesia (lidocaine 15%, Nummit)<br>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. | Drug: Anesthesia (Lidocaine 15%)<br>* As described in arm/group<br>* Other names: Nummit;|
| Experimental: Decongestant and Anesthesia<br>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. | Drug: Decongestants and Anesthesia (oxymetazoline and lidocaine)<br>* As described in arm/group<br>* Other names: Nasivion and Nummit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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) | 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) | At the end of the procedure | 
| Prevalence of adverse effects of procedure | bleeding, gag, nausea, vomiting will be noted | 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 | At the end of the procedure |