Efficacy and safety of multiple doses of tapentadol oral solution in the treatment of moderate to severe acute pain in children aged 2 to <18 years - a randomized, double-blind, placebo-controlled trial.

Tapentadol OS was effective and generally well tolerated in children (≥2 years) for the treatment of moderate to severe acute pain. Across all age groups, palatability and acceptability of tapentadol OS were sufficient to ensure intake compliance. This trial provides evidence that tapentadol OS can be effectively used to treat pain in young patients for whom currently limited labelled treatment options are available.