Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Local Anesthetics,Topical; Other: Simple distraction technique

• Registration Number: NCT03191370
• Lead Sponsor: United Lincolnshire Hospitals NHS Trust

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Study Start: 2021-03-08
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anaesthetic, no distraction	Local Anesthetics,Topical	Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure.
Local Anaesthetic, with distraction	Simple distraction technique	Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention.
Local Anaesthetic, with distraction	Local Anesthetics,Topical	Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention.
No Local Anaesthetic, with distraction	Simple distraction technique	Will receive no local (co-phenylcaine) anesthetic spray with distraction during the procedure. The simple distraction technique is the experimental intervention.

Primary Outcome Measures

Name	Time	Method
Discomfort during procedure	5 minutes	Visual analogue discomfort scale

Trial Locations

Locations (1)

United Lincolnshire Hospitals Trust; 🇬🇧 Lincoln, Research Manager, United Kingdom