Co-Phenylcaine Spray: Can we improve the taste?

Comparing Co-Phenylcaine Forte Nasal Spray versus Co-Phenylcaine Forte Nasal Spray with Vanilla Liquid Flavour (L132184) and Masking Liquid Flavour (50105AB) additives (CoPhenylcaine Zest): a phase III, randomised, double-blind, crossover study.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001335482

Enrollment

Registered

2016-09-26

Start date

2016-02-01

Completion date

2016-03-27

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

CoPhenylcaine Forte Nasal Spray is routinely used in the field of Otorhinolaryngology during ward rounds, clinics and theatre. The active ingredients, lignocaine and phenylephrine hydrochloride anaesthetise and cause vasoconstriction of the nasal passage to allow a clearer visual field for endoscopy with less discomfort for the patient. Multiple studies along with anecdotal evidence almost universally supports the notion that the spray has a distinctly unpleasant taste for patients. As is often done with medications that have an unpleasant taste, we are aiming to improve the overall taste profile and tolerability of CoPhenylcaine for patients, without affecting its efficacy, by adding a concentrated flavour and masking agent to the spray

Interventions

Patients received a one off dose of Lignocaine 5% + Phenylephidrine 0.5%, two actuations in each nostril (100 microlitres /spray), and within 6-36 hours two actuations of Lignocaine (4.8%) + Phenylephidrine (0.48%)+ vanilla concentrate additive (L-132184) and masking flavour (50105AB) titrated to a 4% concentration (2ml of additives added to make 50ml of solution) in each nostril (100 microlitres/spray) or vice versa. The Investigator was responsible for administering all doses of medication.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

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

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

1. Males or females aged between 18-60 years. 2. Employees of Metro South Hospital and Health Service at Princess Alexandra Hospital. 3. Available on two consecutive days from day of consent. 4. Currently healthy and well. 5. Able to read and complete Patient Information and Consent Form and questionnaire in English.

Exclusion criteria

1. Pregnant or possibility of being pregnant. 2. Previous hypersensitivity to local anaesthetics. 3. Recent nasal surgery. 4. Known nasal pathology, including sinusitis which affects daily living. 5. History of cardiac disease.

Outcome results