Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Other: Simple distraction technique
* Drug: Local Anesthetics,Topical


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain during laryngoscopy, Flexible nasal endoscopy