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
Curtin University
22 participants
Nov 18, 2019
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Patients attending an Ear nose and throat (ENT) practice for nasendoscopy examination and minor surgical procedures.
Exclusion Criteria1
- significant oral disease or injury, any known impairment of taste function and any history of cardiac, liver or kidney conditions.
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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.
Locations(1)
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ACTRN12619001493134