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

NCT03620513 | Completed Phase 4 DMC

• 1 other identifier: 142
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Throat Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Discomfort of pre-treatment as VAS 1-10

  four minutes from the first spray

• Prevalence of adverse effects of pre-medication

  four minutes from the first spray

• Pain due to procedure as VAS 1-10

  At the end of the procedure

• Ease of procedure as VAS 1-10

  At the end of the procedure

• Prevalence of adverse effects of procedure

  At the end of the procedure

Study Arms (4)

Normal Saline nasal spray

PLACEBO COMPARATOR

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

Drug: Normal saline

Decongestant (Oxymetazoline 0.05%)

EXPERIMENTAL

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%)

Anesthesia (lidocaine 15%, Nummit)

EXPERIMENTAL

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%)

Decongestant and Anesthesia

EXPERIMENTAL

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)

Interventions

Decongestant (oxymetazoline 0.05%) DRUG

As described in arm/group

Also known as: Nasivion

Decongestant (Oxymetazoline 0.05%)

Anesthesia (Lidocaine 15%) DRUG

As described in arm/group

Also known as: Nummit

Anesthesia (lidocaine 15%, Nummit)

Decongestants and Anesthesia (oxymetazoline and lidocaine) DRUG

As described in arm/group

Also known as: Nasivion and Nummit

Decongestant and Anesthesia

Normal saline DRUG

Spray of normal saline as premedication

Normal Saline nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing fiberoptic naso pharyngo laryngoscopy in OPD setting
• Consent to study
• above 18 years

You may not qualify if:

• gross nasal mass
• pregnants
• known hypersensitivity to the drugs used for premedication
• who cannot respond to questionnaire during data collection

Sponsors & Collaborators

• Lumbini Medical College: lead

Study Sites (1)

Lumbini Medical College

Tānsen, Palpa, 32500, Nepal

Location

MeSH Terms

Interventions

Nasal Decongestants; Anesthesia; Oxymetazoline; Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Vasoconstrictor Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Respiratory System Agents; Anesthesia and Analgesia; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anup Acharya, MS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four arms of study group with equal number of subjects in each group

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: August 8, 2018
• Study Start: September 1, 2018
• Primary Completion: January 16, 2019
• Study Completion: February 16, 2019
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: As soon as article is published online. It will be available for good.

Locations

NE (1)