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Randomized Controlled Trial Clinical Trial
A randomized, double-blind, placebo-controlled study of the efficacy of tetracaine gel (Ametop) for pain relief during topical photodynamic therapy.
- M V Holmes, R S Dawe, J Ferguson, and S H Ibbotson.
- Photobiology Unit, University Department of Dermatology, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK.
- Br. J. Dermatol. 2004 Feb 1;150(2):337-40.
BackgroundMany patients find topical 5-aminolaevulinic acid (ALA) photodynamic therapy (PDT) painful. Local anaesthetics are not routinely used and their effect on PDT pain has not been examined.ObjectivesTo evaluate the efficacy of tetracaine gel (Ametop) for pain relief during and after PDT.MethodsA prospective, double-blind, placebo-controlled study of 42 patients with lesions (< or =2 cm diameter) of superficial nonmelanoma skin cancer or dysplasia. Patients were randomized to either tetracaine (4% w/w) (n=22) or vehicle (n=20) gel under occlusion for 1 h pre-irradiation. Pain was assessed during and after irradiation using a visual analogue scale (VAS) and faces pain scale.ResultsPatients who received tetracaine gel experienced only slightly less pain during PDT (median VAS 4) compared with those who received placebo (median VAS 4.5) (95% confidence interval for difference 0-3, P=0.08). No significant difference in pain was experienced between the treatment groups immediately after irradiation or later.ConclusionsWhen compared with placebo, tetracaine gel did not significantly reduce pain during or after PDT for small lesions of superficial basal cell carcinoma, Bowen's disease or actinic keratosis.
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