NCT03620513

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Lumbini Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Throat Disorder

Interventions

Type	Name	Description
DRUG	Decongestant (oxymetazoline 0.05%)	As described in arm/group
DRUG	Anesthesia (Lidocaine 15%)	As described in arm/group
DRUG	Decongestants and Anesthesia (oxymetazoline and lidocaine)	As described in arm/group
DRUG	Normal saline	Spray of normal saline as premedication

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-01-16
• Completion: 2019-02-16
• First posted: 2018-08-08
• Last updated: 2020-03-09

Locations

1 site across 1 country: Nepal