Does topical amethocaine gel reduce the pain of venepuncture in newborn infants? A randomised double blind controlled trial

Background-Topical amethocaine provides effective pain relief during venepu ncture in children, and has been shown to have a local anaesthetic action i n the newborn. Aim-To investigate the effect of topical amethocaine on the pain of venepun cture in the newborn. Design-Randomised double blind placebo controlled trial. Subjects-Forty newborn infants, gestation 27-41 weeks (median 33), age 2-17 days (median 7), undergoing routine venepuncture. Method-A 1.5 g portion of 4% (w/w) amethocaine gel (Ametop; Smith and Nephe w, Hull, UK) or placebo was applied to the skin under occlusion for one hou r, then wiped away. Venepuncture was performed five minutes later. Facial r eaction and cry were recorded on videotape. Pain was assessed using a valid ated adaptation of the neonatal facial coding system. Five features were sc ored at one second intervals for five seconds before and after venepuncture . No or minimal pain was defined as a cumulative score of below 10 (out of 25) in the five seconds after needle insertion. Each author scored the tape s independently. Results-There was close agreement on scoring of the tapes. One infant was e xcluded because of restlessness before the venepuncture. Of 19 amethocaine treated infants, 16 (84%) showed little or no pain compared with six of 20 (30%) in the placebo group (p = 0.001). The median cumulative neonatal faci al coding system score over five seconds after needle insertion was 3 compa red with 16 in the placebo group (p = 0.001). Of the 19 amethocaine treated infants, 15 (79%) did not cry compared with five of 20 (25%) placebo treat ed infants (p = 0.001). No local reaction to amethocaine was seen. Conclusion-Topical amethocaine provides effective pain relief during venepu ncture in the newborn.