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.

ABSTRACT:

Background

Well-controlled trials of analgesics in the pediatric population are scarce. Tapentadol is a strong centrally acting analgesic which has undergone a pediatric development program investigating its suitability for treating moderate to severe acute pain across the entire pediatric age range from birth to adolescence. Here, we report data from a pivotal Phase III trial performed as part of this development program.

Patients and methods

This randomized, double-blind, placebo-controlled, multicenter clinical trial investigated efficacy and safety/tolerability of multiple tapentadol oral solution doses (OS; target dose 1.25 mg/kg) in the treatment of postsurgical acute pain. Data for patients aged 2 to <18 years are reported here. The main objective of the trial was to

SUBMITTER: Beuter C 

PROVIDER: S-EPMC6859087 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature