Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191370
• Other study ID #: 280217ArshadFaisal
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: United Lincolnshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Simple distraction technique
Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed.

Drug:
• Local Anesthetics,Topical
Anesthetic spray

Locations

Country	Name	City	State
United Kingdom	United Lincolnshire Hospitals Trust	Lincoln	Research Manager

Sponsors (1)

Lead Sponsor	Collaborator
United Lincolnshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort during procedure	Visual analogue discomfort scale	5 minutes