NCT03191370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
3.7 years until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

June 7, 2017

Last Update Submit

February 6, 2023

Conditions

Pain

Keywords

pain during laryngoscopy, Flexible nasal endoscopy

Outcome Measures

Primary Outcomes (1)

  • Discomfort during procedure

    Visual analogue discomfort scale

    5 minutes

Study Arms (4)

Local Anaesthetic, no distraction

ACTIVE COMPARATOR

Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure.

Drug: Local Anesthetics,Topical

Local Anaesthetic, with distraction

EXPERIMENTAL

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 techniqueDrug: Local Anesthetics,Topical

No Local Anaesthetic without distraction

NO INTERVENTION

Will receive no local (co-phenylcaine) anaesthetic spray without distraction during the procedure.

No Local Anaesthetic, with distraction

EXPERIMENTAL

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

Interventions

Simple distraction techniqueOTHER

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

Local Anaesthetic, with distractionNo Local Anaesthetic, with distraction
Local Anesthetics,TopicalDRUG

Anesthetic spray

Also known as: Co-phenylcaine
Local Anaesthetic, no distractionLocal Anaesthetic, with distraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Lincolnshire Hospitals Trust

Lincoln, Research Manager, LN57XD, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 19128620BACKGROUND

  • 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.

    PMID: 12472516BACKGROUND

  • 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.

    PMID: 23317724BACKGROUND

  • 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.

    PMID: 16620333BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Faisal A Arshad, MRCS

    United Lincolnshire NHS trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 19, 2017

Study Start

March 8, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)