Comparison of the effect of an anaesthetic spray and an anaesthetic spray with additional flavouring in providing anaesthesia for nasendoscopy

A randomised, cross-over clinical trial to evaluate the equivalence of a reformulated Co-phenylcaine spray incorporating taste masking and flavouring agents as compared to the currently marketed Co-phenylcaine Forte spray in providing anaesthesia for nasendoscopy procedures

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001493134

Acronym

None

Enrollment

Registered

2019-10-29

Start date

2019-11-18

Completion date

2020-01-20

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of this study will be to compare the effectiveness of the currently marketed Co-phenylcaine Forte spray with a reformulated Co-phenylcaine spray incorporating taste masking and flavouring agents (Co-Phenylcaine Neo spray), when administered intra-nasally, in a group of patients undergoing nasendoscopy. The study will be an equivalence trail (10% equivalence margin) using a randomised, blinded, cross-over design with participants undergoing two nasendoscopy procedures approximately 4 weeks apart. Participants will be asked to rate the taste associated with the spray and rate any pain or discomfort they feel following insertion of the nasendoscope. It is hypothesised that both interventions will have an equivalent effect in reducing discomfort and the new formulation will have a preferred taste.

Interventions

Co-Phenylcaine Forte local anaesthetic spray. 100 ul spray containing 5 mg lignocaine hydrochloride and 0.5 mg phenylephrine. 5 sprays administered by ENT surgeon per nostril. The anaesthetic spray will be administered 10 minutes prior to nasendoscopy. Cross over with wash out period of 4-6 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients attending an Ear nose and throat (ENT) practice for nasendoscopy examination and minor surgical procedures.

Exclusion criteria

significant oral disease or injury, any known impairment of taste function and any history of cardiac, liver or kidney conditions.

Outcome results