Clinical trial

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

NCT03191370

Name

280217ArshadFaisal

Description

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.

Trial arms

Trial start

2021-03-08

Estimated PCD

2022-12-01

Trial end

2022-12-01

Status

Completed

Treatment

Simple distraction technique

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

Arms:

Local Anaesthetic, with distraction, No Local Anaesthetic, with distraction

Local Anesthetics,Topical

Anesthetic spray

Arms:

Local Anaesthetic, no distraction, Local Anaesthetic, with distraction

Other names:

Co-phenylcaine

Size

Primary endpoint

Discomfort during procedure

5 minutes

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2023-02-08

1 organization

1 product

1 indication

Organization

United Lincolnshire Hospitals NHS Trust

Product

Local Anesthetics

Indication

Pain