M.V.Holmes was a fourth year medical student from St Andrew's University Medical School when this work was performed.
A randomized, double-blind, placebo-controlled study of the efficacy of tetracaine gel (Ametop®) for pain relief during topical photodynamic therapy
Article first published online: 19 FEB 2004
British Journal of Dermatology
Volume 150, Issue 2, pages 337–340, February 2004
How to Cite
Holmes, M.V., Dawe, R.S., Ferguson, J. and Ibbotson, S.H. (2004), A randomized, double-blind, placebo-controlled study of the efficacy of tetracaine gel (Ametop®) for pain relief during topical photodynamic therapy. British Journal of Dermatology, 150: 337–340. doi: 10.1111/j.1365-2133.2004.05652.x
- Issue published online: 19 FEB 2004
- Article first published online: 19 FEB 2004
- Accepted for publication 14 May 2003
- 5-aminolaevulinic acid;
- local anaesthetic;
- photodynamic therapy;
- visual analogue scale
Background Many 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.
Objectives To evaluate the efficacy of tetracaine gel (Ametop®) for pain relief during and after PDT.
Methods A prospective, double-blind, placebo-controlled study of 42 patients with lesions (≤ 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.
Results Patients 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.
Conclusions When 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.