A randomized, double-blind, placebo-controlled study of oral oxycodone plus acetaminophen for the treatment of pain in photodynamic therapy on port wine stains

摘要

Background: The major side-effect of photodynamic therapy (PDT) on port wine stains (PWS) is pain during the treatment. Although several strategies for controlling the pain during topical PDT achieve a reduction in the levels of pain, none were completely effective and convenient. This randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of an oral analgesic for the treatment of pain in PDT on PWS. Methods: Fifty-eight patients with PWS on the face were included. The treatment and placebo groups were selected by computer randomization. The patients, doctor and statistician were blinded to the patients' groups. The analgesic contained 5 mg of oxycodone in combination with 325 mg of acetaminophen. The patient took the tablet orally 30 min before PDT. The patient was injected intravenously with 4-5 mg/kg photosensitizer PSD-007 within 5 min, and then the lesion was exposed to a 532 nm laser immediately for 30-60 min at 100mW/cm~2. The intensity of the pain during irradiation, the characteristic and beginning time of pain, and adverse effects were recorded. A visual analog scale (VAS) was used to assess the pain. Results and conclusions: The time of the pain beginning was 8.31 ±4.58 min in the treatment group and 7.10 ± 3.54 min in the placebo group, which was not significantly different (P=0.266). The VAS score in the treatment group was 7.88 ± 1.52 compared with 8.17 ± 1.12 in the placebo group, with no significant difference (P=0.422). The subgroup of age, gender, lesion location and classification between two groups had similar VAS score (P ＞ 0.05). No serious adverse events were reported. This study found that oral oxycodone 5 mg/acetaminophen 325 mg was completely ineffective for pain relief, and age, gender, lesion location and classification did not influence the pain perception and the analgesic effect. The challenge of controlling pain during PDT on PWS remains.