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CompletedPhase 3ACTRN12616001335482

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.

Sponsor

Stuart Bailey

Enrollment

90 participants

Start Date

Feb 1, 2016

Study Type

Interventional

Conditions

Nasendoscopy

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

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria5

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

Exclusion Criteria5

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

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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%) + Phenyleph

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.

Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12616001335482