PMID- 32009813
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220412
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 12
DP  - 2019
TI  - 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.
PG  - 3099-3112
LID - 10.2147/JPR.S207010 [doi]
AB  - 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 investigate if oral tapentadol administration compared to placebo reduces 
      the use of supplemental opioid analgesic medication within the first 24 hrs of 
      treatment. Other investigated parameters included taste and palatability of the 
      trial medication, adverse events (AEs), vital signs, and laboratory parameters. 
      RESULTS: A total of 160 patients were included (placebo n=52, tapentadol n=108). 
      It was shown that the total amount of supplemental opioid analgesic medication 
      used in the first 24 hrs was significantly lower in tapentadol patients than 
      placebo patients (p=0.0154). Taste and palatability of tapentadol OS was well 
      perceived by most patients. Treatment-emergent AEs were reported in 50% of 
      patients treated with placebo vs 57.4% in those exposed to tapentadol, most 
      commonly vomiting, nausea, and constipation in both treatment groups. CONCLUSION: 
      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.
CI  - (c) 2019 Beuter et al.
FAU - Beuter, Christoph
AU  - Beuter C
AUID- ORCID: 0000-0002-7083-0726
AD  - Grunenthal GmbH, Aachen, Germany.
FAU - Volkers, Gisela
AU  - Volkers G
AUID- ORCID: 0000-0002-9048-4955
AD  - Grunenthal GmbH, Aachen, Germany.
FAU - Radic, Tatjana
AU  - Radic T
AD  - Grunenthal GmbH, Aachen, Germany.
FAU - Goldberg, Jutta
AU  - Goldberg J
AD  - Grunenthal GmbH, Aachen, Germany.
FAU - van den Anker, John
AU  - van den Anker J
AD  - Division of Paediatric Pharmacology and Pharmacometrics, University of Basel 
      Children's Hospital, Basel, Switzerland.
AD  - Division of Clinical Pharmacology, Children's National Medical Center, 
      Washington, DC, USA.
LA  - eng
PT  - Journal Article
DEP - 20191113
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC6859087
OTO - NOTNLM
OT  - efficacy
OT  - moderate to severe acute pain
OT  - pediatric pain management
OT  - safety
OT  - tapentadol oral solution
COIS- Christoph Beuter, Gisela Volkers, Tatjana Radic, and Jutta Goldberg are employees 
      of Grunenthal GmbH. John van den Anker is a paid consultant for Grunenthal. The 
      authors report no other conflicts of interest in this work.
EDAT- 2020/02/06 06:00
MHDA- 2020/02/06 06:01
PMCR- 2019/11/13
CRDT- 2020/02/04 06:00
PHST- 2019/02/27 00:00 [received]
PHST- 2019/09/30 00:00 [accepted]
PHST- 2020/02/04 06:00 [entrez]
PHST- 2020/02/06 06:00 [pubmed]
PHST- 2020/02/06 06:01 [medline]
PHST- 2019/11/13 00:00 [pmc-release]
AID - 207010 [pii]
AID - 10.2147/JPR.S207010 [doi]
PST - epublish
SO  - J Pain Res. 2019 Nov 13;12:3099-3112. doi: 10.2147/JPR.S207010. eCollection 2019.