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Sublingual buprenorphine (SLB) is being used increasingly for treatment of moderate to severe pain in children. The aim of this study was to evaluate the analgesic efficacy and safety of SLB in children with moderate to severe pain. This was a prospective, double-blind, placebo-controlled trial that was conducted between April 2007 and March 2008 in 9 medical/surgical pediatric emergency departments in Italy. Patients, age 2 to 16 years, presenting with moderate to severe pain (numerical rating scale [NRS] score ≥4), were eligible for inclusion. The study included 576 patients. The median (quartiles) age was 7 (5-12) years and the sex distribution (male/female) was 354/222. The median (quartiles) baseline pain score was 8 (5-10). The majority of patients (76.7%) were treated for less than 10 minutes and reported a low level of satisfaction. Among the 556 patients for whom a physician assessed global pain intensity before study drug, the median (quartiles) NRS score for children 0b46394aab
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