| Summary: | Richard F Howard,1 Tatjana Radic,2 Melanie Sohns,2 Mariëlle Eerdekens,2 Andrea Waßmuth2 1Department of Anaesthesia and Pain Medicine, Great Ormond Street Hospital and the GOS-UCL Institute of Child Health, London, UK; 2Grünenthal GmbH, Aachen, GermanyCorrespondence: Richard F HowardDepartment of Anaesthesia and Pain Medicine, Great Ormond Street Hospital and the GOS-UCL Institute of Child Health, London WC1N 3JH, UKTel +44 2078298865Email R.Howard@ucl.ac.ukPurpose: 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: tapentadol, analgesic, prolonged-release, pain, child, adolescent
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