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Two‐step irradiance schedule versus single‐dose tramadol sustained‐release tablets for pain control during topical 5‐aminolevulinic acid‐photodynamic therapy of condyloma acuminatum in Chinese patients: A randomized comparative study
Author(s) -
Mchepange Uwesu O.,
Huang ChunYan,
Sun Yi,
Tu YaTing,
Tao Juan
Publication year - 2014
Publication title -
lasers in surgery and medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.888
H-Index - 112
eISSN - 1096-9101
pISSN - 0196-8092
DOI - 10.1002/lsm.22243
Subject(s) - medicine , randomized controlled trial , anesthesia , surgery , tramadol , photodynamic therapy , analgesic , chemistry , organic chemistry
Background and Objective Photodynamic therapy with 5‐aminolevulinic acid (ALA‐PDT) offers promising results for the treatment of condyloma acuminatum. However, patients have to dwell with pain to benefit from this otherwise effective and safe “off‐label” treatment modality. Several techniques have been explored to control ALA‐PDT‐induced pain, but the desperate search for a universally accepted method is still ongoing. This study compares the two‐step irradiance approach with single‐dose administration of 100 mg tramadol sustained‐release tablets for pain induced by ALA‐PDT of condyloma acuminatum in Chinese patients. Patients and Methods Adult Chinese patients with condyloma acuminatum were enrolled in a randomized comparative study. Pain levels were compared using the Numeric Rating Scale (NRS) at pre‐defined assessment points during and after irradiation. Results The pain was dominated by characteristics such as burning and pricking and was almost always local and superficial. During Irradiation The median pain scores were lower in the two‐step irradiance group at 1 minute ( U = 621.5, P = 0.002) but higher at 20 minutes ( U = 585.5, P = 0.002). The median pain scores between the two groups did not differ significantly at other assessment points. The pain was moderate in both groups and peaked earlier in the analgesics group (median: 5 minutes) but later in the two‐step irradiance group (median: 15 minutes). After Irradiation The pain was generally mild. The median pain scores were equal at each assessment point, except at 3 hours where the median was lower in the analgesics group (1.0) as compared with the two‐step irradiance group (2.0) ( U = 725.0, P = 0.056). Conclusions Pain in the two‐step irradiance protocol is irradiance‐dependent. The two‐step irradiance approach produces significant benefits over analgesics during the initial stages of therapy but analgesics offer significant benefits thereafter. There are potential benefits of combining the two approaches in minimizing ALA‐PDT‐induced pain. Lasers Surg. Med. 46:389–395, 2014. © 2014 Wiley Periodicals, Inc.