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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
160
As described in arm/group
As described in arm/group
As described in arm/group
Lumbini Medical College
Tānsen, Palpa, Nepal
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)
Time frame: At the end of the procedure
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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: At the end of the procedure
Prevalence of adverse effects of procedure
bleeding, gag, nausea, vomiting will be noted
Time frame: 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
Time frame: At the end of the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Spray of normal saline as premedication