Table 5.

Pediatric clinical program for the strong analgesic tapentadol in treating acute pain

Trial no.	Brief trial description	Objectives	Age subgroups and rationale
1	Single dose, oral solution Children/adolescents aged 2 to <18 years Postsurgical moderate to severe acute pain needing opioid treatment	Primary: pharmacokinetics Secondary: safety and exploratory efficacy	Age subgroups: 12 to <18, 6 to <12, 2 to <6 years *
2	Single dose, oral solution Neonates/infants aged 0 to <2 years Postsurgical moderate to severe acute pain needing opioid treatment	Primary: pharmacokinetics Secondary: safety and exploratory efficacy	Age subgroups: 6 months to <2 years, 1 month to <6 months, birth to <1 month *
3	Single dose, intravenous Neonates/infants aged preterm to <2 years Postsurgical moderate to severe acute pain needing opioid treatment	Primary: pharmacokinetics Secondary: safety and exploratory efficacy	Age subgroups: 6 months to <2 years, 1 month to <6 months, birth (>37 weeks gestational age) to <1 month preterms >32<37 weeks gestational age *
4	Repeat dose, oral solution Children/adolescents aged 2 to <18 years Postsurgical acute pain needing opioid treatment	Primary: efficacy and safety	Age subgroups: 12 to <18, 6 to <12, 2 to <6 Efficacy and safety trial with treatment evaluation period up to 96 hrs.

Note: *Safe and efficacious exposure known in adults also targeted in children.