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, S. H. Ibbotson

    Research output: Contribution to journalArticle

    79 Citations (Scopus)

    Abstract

    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.

    Original languageEnglish
    Pages (from-to)337-340
    Number of pages4
    JournalThe British journal of dermatology
    Volume150
    Issue number2
    DOIs
    Publication statusPublished - Feb 2004

    Fingerprint

    Tetracaine
    Photochemotherapy
    Gels
    Placebos
    Pain
    Visual Analog Scale
    Bowen's Disease
    Actinic Keratosis
    Aminolevulinic Acid
    Facial Pain
    Basal Cell Carcinoma
    Skin Neoplasms
    Local Anesthetics
    Confidence Intervals

    Keywords

    • Photosensitivity Disorders
    • Double-Blind Method
    • Humans
    • Photochemotherapy
    • Aged
    • Pain
    • Carcinoma, Basal Cell
    • Skin Neoplasms
    • Anesthetics, Local
    • Tetracaine
    • Bowen's Disease
    • Gels
    • Prospective Studies
    • Aged, 80 and over
    • Adult
    • Treatment Outcome
    • Middle Aged
    • Administration, Topical
    • Female
    • Male

    Cite this

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    title = "A randomized, double-blind, placebo-controlled study of the efficacy of tetracaine gel (Ametop) for pain relief during topical photodynamic therapy",
    abstract = "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.",
    keywords = "Photosensitivity Disorders, Double-Blind Method, Humans, Photochemotherapy, Aged, Pain, Carcinoma, Basal Cell, Skin Neoplasms, Anesthetics, Local, Tetracaine, Bowen's Disease, Gels, Prospective Studies, Aged, 80 and over, Adult, Treatment Outcome, Middle Aged, Administration, Topical, Female, Male",
    author = "Holmes, {M. V.} and Dawe, {R. S.} and J. Ferguson and Ibbotson, {S. H.}",
    year = "2004",
    month = "2",
    doi = "10.1111/j.1365-2133.2004.05652.x",
    language = "English",
    volume = "150",
    pages = "337--340",
    journal = "British Journal of Dermatology",
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    A randomized, double-blind, placebo-controlled study of the efficacy of tetracaine gel (Ametop) for pain relief during topical photodynamic therapy. / Holmes, M. V.; Dawe, R. S.; Ferguson, J.; Ibbotson, S. H.

    In: The British journal of dermatology, Vol. 150, No. 2, 02.2004, p. 337-340.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - A randomized, double-blind, placebo-controlled study of the efficacy of tetracaine gel (Ametop) for pain relief during topical photodynamic therapy

    AU - Holmes, M. V.

    AU - Dawe, R. S.

    AU - Ferguson, J.

    AU - Ibbotson, S. H.

    PY - 2004/2

    Y1 - 2004/2

    N2 - 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.

    AB - 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.

    KW - Photosensitivity Disorders

    KW - Double-Blind Method

    KW - Humans

    KW - Photochemotherapy

    KW - Aged

    KW - Pain

    KW - Carcinoma, Basal Cell

    KW - Skin Neoplasms

    KW - Anesthetics, Local

    KW - Tetracaine

    KW - Bowen's Disease

    KW - Gels

    KW - Prospective Studies

    KW - Aged, 80 and over

    KW - Adult

    KW - Treatment Outcome

    KW - Middle Aged

    KW - Administration, Topical

    KW - Female

    KW - Male

    U2 - 10.1111/j.1365-2133.2004.05652.x

    DO - 10.1111/j.1365-2133.2004.05652.x

    M3 - Article

    VL - 150

    SP - 337

    EP - 340

    JO - British Journal of Dermatology

    JF - British Journal of Dermatology

    SN - 0007-0963

    IS - 2

    ER -