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Completed

NCT Number: NCT03191370

Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United Lincolnshire Hospitals Trust

Lincoln, Research Manager, LN57XD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simple distraction technique

Other

Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed.

Local Anesthetics,Topical

Drug

Anesthetic spray

Other names: Co-phenylcaine

Primary outcomes

  1. Discomfort during procedure

    Time frame: 5 minutes

    Visual analogue discomfort scale

Sponsors and collaborators

Lead sponsor

United Lincolnshire Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2017
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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