Tapentadol Prolonged Release for Long-Term Treatment of Pain in Children.

ABSTRACT:

Purpose

Investigation of the efficacy and safety of tapentadol prolonged release (PR) compared with morphine PR for long-term treatment of pain in children.

Patients and methods

Children aged 6 to <18 years requiring long-term treatment with opioids were studied in a 12-month, 2-part, multi-center trial: Part 1, 14-day open-label, randomized, active-controlled, parallel group non-inferiority trial comparing twice daily tapentadol PR with morphine PR; Part 2, open-label treatment with tapentadol PR for up to 12 months or no treatment "safety observation period". Pain intensity was rated with visual analogue scale or Faces Pain Scale-Revised, and non-inferiority was assessed by comparison of "treatment responders" (those completing the 14-day treatment period and showing pre-d

SUBMITTER: Howard RF 

PROVIDER: S-EPMC7725093 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature