Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

Pragmatic Randomised Controlled Trial Assessing the Use of a Simple Distraction Technique to Reduce Discomfort When Performing Transnasal Fiberoptic Laryngoscopy in the ENT Outpatient Clinic

To compare the effectiveness of reducing discomfort during flexible nasal endoscopy using simple distraction techniques compared to topical anaesthetic spray and a control group that does not receive topical anaesthetic spray or a distraction technique.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Local Anesthetics,Topical; Other: Simple distraction technique

Detailed Description

In this randomised controlled study patients will be randomly allocated into one of four groups; the first group will receive topical (co-phenylcaine) anaesthetic spray without distraction, the second group will receive topical (co-phenylcaine) anaesthetic spray with distraction, the thirds group will receive no topical (co-phenylcaine) anaesthetic spray without distraction and the fourth group will receive no topical (co-phenylcaine) anaesthetic spray with distraction. The distraction technique that will be employed is counting backwards from 30 to 1 in even numbers only. All flexible nasal endoscopies will be performed by either of the two most senior clinicians involved in the study. The procedure will be carried out in standard outpatient clinic room setting. Post procedural discomfort assessments will be undertaken using a visual analogue scale (VAS). Power calculations shows that >24 patients would result in an adequately powered study (>80%). Data analysis will be undertaken by SPSS and independent T-tests will be performed to assess for statistical significance.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Research Manager
    • Lincoln, Research Manager, United Kingdom, LN57XD
      • United Lincolnshire Hospitals Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and Female participants aged 18+
• Patient requires flexible fiberoptic transnasal laryngoscopy.
• Patient has no preferences in relation to which arm of the study they would like to be in.

Exclusion Criteria:

• Flexible nasal endoscopy not indicated
• Local anaesthetic required for other reasons - e.g. vasoconstrictor effects
• Patient has a clear preference to which group they are randomised to
• Significant sino-nasal disease
• Patient under the age of 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Local Anaesthetic, no distraction; Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure.	Drug: Local Anesthetics,Topical; Anesthetic spray; Other Names: Co-phenylcaine
EXPERIMENTAL: Local Anaesthetic, with distraction; Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention.	Drug: Local Anesthetics,Topical; Anesthetic spray; Other Names: Co-phenylcaine; Other: Simple distraction technique; Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed.
NO_INTERVENTION: No Local Anaesthetic without distraction; Will receive no local (co-phenylcaine) anaesthetic spray without distraction during the procedure.
EXPERIMENTAL: No Local Anaesthetic, with distraction; Will receive no local (co-phenylcaine) anesthetic spray with distraction during the procedure. The simple distraction technique is the experimental intervention.	Other: Simple distraction technique; Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort during procedure	Visual analogue discomfort scale	5 minutes

Collaborators and Investigators

• Sponsor: United Lincolnshire Hospitals NHS Trust
• Investigators: Principal Investigator: Faisal A Arshad, MRCS, United Lincolnshire NHS trust

Publications and helpful links

General Publications

• Conlin AE, McLean L. Systematic review and meta-analysis assessing the effectiveness of local anesthetic, vasoconstrictive, and lubricating agents in flexible fibre-optic nasolaryngoscopy. J Otolaryngol Head Neck Surg. 2008 Apr;37(2):240-9.
• Cain AJ, Murray DP, McClymont LG. The use of topical nasal anaesthesia before flexible nasendoscopy: a double-blind, randomized controlled trial comparing cophenylcaine with placebo. Clin Otolaryngol Allied Sci. 2002 Dec;27(6):485-8. doi: 10.1046/j.1365-2273.2002.00608.x.
• Choudhury N, Amer I, Daniels M, Wareing MJ. Audiovisual distraction reduces pain perception during aural microsuction. Ann R Coll Surg Engl. 2013 Jan;95(1):34-6. doi: 10.1308/003588413X13511609955535.
• Pothier DD, Raghava N, Monteiro P, Awad Z. A randomized controlled trial: is water better than a standard lubricant in nasendoscopy? Clin Otolaryngol. 2006 Apr;31(2):134-7. doi: 10.1111/j.1749-4486.2006.01173.x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2021
• Primary Completion (ACTUAL): December 1, 2022
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (ACTUAL): June 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pain during laryngoscopy, Flexible nasal endoscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 280217ArshadFaisal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No