Clinical trial NCT03191370: Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain during laryngoscopy, Flexible nasal endoscopy
Lead sponsor: United Lincolnshire Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discomfort during procedure
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals Trust
state: Research Manager
Study officials:
affiliation: United Lincolnshire NHS trust
name: Faisal A Arshad, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.