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

NCT ID: NCT03620513

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-02-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Normal Saline nasal spray

Two spray (via atomizer) of normal saline in each nostril five minutes prior to fiberoptic procedure

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Spray of normal saline as premedication

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.

Group Type: EXPERIMENTAL

Decongestant (oxymetazoline 0.05%)

Intervention Type: DRUG

As described in arm/group

Anesthesia (lidocaine 15%, Nummit)

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.

Group Type: EXPERIMENTAL

Anesthesia (Lidocaine 15%)

Intervention Type: DRUG

As described in arm/group

Decongestant and Anesthesia

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.

Group Type: EXPERIMENTAL

Decongestants and Anesthesia (oxymetazoline and lidocaine)

Intervention Type: DRUG

As described in arm/group

Interventions

Decongestant (oxymetazoline 0.05%)

As described in arm/group

Intervention Type: DRUG

Anesthesia (Lidocaine 15%)

As described in arm/group

Intervention Type: DRUG

Decongestants and Anesthesia (oxymetazoline and lidocaine)

As described in arm/group

Intervention Type: DRUG

Normal saline

Spray of normal saline as premedication

Intervention Type: DRUG

Other Intervention Names

Nasivion; Nummit; Nasivion and Nummit

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumbini Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anup Acharya, MS

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Lumbini Medical College

Tānsen, Palpa, Nepal

Countries

Nepal

Other Identifiers

142

Identifier Type: -

Identifier Source: org_study_id