Efficacy of ketoprofen lysine salt and paracetamol/acetaminophen to reduce pain during rapid maxillary expansion: A randomized controlled clinical trial

摘要

Background Rapid maxillary expansion (RME) is an orthopaedic procedure indicated for a wide variety of clinical conditions. Aim The aim of the study was to compare the effects of ketoprofen lysine salt (KLS) vs paracetamol/acetaminophen (P) on pain perception during RME. Design One hundred and fifty-one subjects (mean age 8.6 year) were enrolled in this prospective controlled clinical trial according to inclusion criteria: prepuberal stage of development, negative posterior transverse interarch discrepancy, non-concurrent use of other drugs. First phase: n.40 allocated to Group 1 used 40 mg of KLS, n.40 to Group 2 used 250 mg of P, n.36 to Group 3 as control group. Second phase: n.35 allocated to Group 4 used 40 mg ketoprofen lysine salt once a day for the first 3 days of activation. Pain experience was reported on a numeric rating scale (0-4) and a 100-mm visual analogue scale. Pain perception was tested with the Mann-Whitney test (P 0.05). Results Pain perception was higher during the first 3 days of activation and it was described as mild to moderate. Group 1 experienced significantly less pain during the fourth, fifth, and sixth day (P 0.05) compared with Group 2. Patients of the Group 4 reported significantly lower pain during the whole period of RME activation (P 0.05). Conclusions The perceived higher pain was reported during the second and third day of expansion. The analgesic effect of KLS is more effective than P during the fourth, fifth, and sixth day. The use of KLS during the first 3 days of activation seems to be able reducing pain during the whole active phase.