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

Richard F Howard; Tatjana Radic; Melanie Sohns; Mariëlle Eerdekens; Andrea Waßmuth

doi:10.2147/JPR.S272751

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

J Pain Res. 2020 Nov 30:13:3157-3170. doi: 10.2147/JPR.S272751. eCollection 2020.

Authors

Richard F Howard¹, Tatjana Radic², Melanie Sohns², Mariëlle Eerdekens², Andrea Waßmuth²

Affiliations

¹ Department of Anaesthesia and Pain Medicine, Great Ormond Street Hospital and the GOS-UCL Institute of Child Health, London, UK.
² Grünenthal GmbH, Aachen, Germany.

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-defined changes in pain rating) in each group.

Results: Twenty-three of 48 centers enrolled 73 patients. In Part 1, 45 and 24 patients received tapentadol or morphine, respectively, of which 40 and 22 completed 14-day treatment. In Part 2, thirty-six and 58 patients entered the tapentadol PR or observation periods, respectively, with 20/36 completing at least 12 weeks of treatment; 10 of the 36 had received morphine in Part 1. Forty-four of the 58 patients in the safety observation period had received tapentadol. Tapentadol PR was non-inferior to morphine PR (lower limit of confidence interval above negative non-inferiority margin of -0.2) in Part 1. Rates of adverse events were as expected with nausea (22.2%) and constipation (15.6%) in the tapentadol PR group, and with vomiting (33.3%), nausea and constipation (each 16.7%) in the morphine PR group. No new safety issues were identified; the safety profile of tapentadol over the 12 months treatment and observation periods was comparable to that established in subjects >18 years old.

Conclusion: Tapentadol PR was well tolerated and equivalent to morphine PR for both efficacy and safety in children (6 to <18 years old) requiring long-term treatment with opioids.

Keywords: adolescent; analgesic; child; pain; prolonged-release; tapentadol.