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

Throat Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620513
• Other study ID #: 142
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: February 16, 2019

Study information

• Verified date: March 2020
• Source: Lumbini Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators would like to study whether topical anesthesia or decongestant or their combination provide any benefit to the patients undergoing FOL.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Throat Disorder

Intervention

Drug:
• Decongestant (oxymetazoline 0.05%)
As described in arm/group
• Anesthesia (Lidocaine 15%)
As described in arm/group
• Decongestants and Anesthesia (oxymetazoline and lidocaine)
As described in arm/group
• Normal saline
Spray of normal saline as premedication

Locations

Country	Name	City	State
Nepal	Lumbini Medical College	Tansen	Palpa

Sponsors (1)

Lead Sponsor	Collaborator
Lumbini Medical College

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Prevalence of adverse effects of procedure	bleeding, gag, nausea, vomiting will be noted	At the end of the procedure
Secondary	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