A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain

Summary

The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product (IMP) in children and adolescents who had undergone surgery that would produce moderate to severe pain during opioid treatment.

Timeline

Start

2015-02-19

Primary completion

2019-03-03

Completion

2019-03-14

Outcome

Met primary endpoint

registry analysis (superiority test); Tapentadol (From 2 to <18 Years) vs Placebo (From 2 to <18 Years); p = 0.0404; Mean Difference (Final Values) -0.05 (95% CI -0.09 to 0) NCT02081391 ↗

registry analysis (superiority test); Tapentadol (From 2 to <18 Years) vs Placebo (From 2 to <18 Years); p = 0.0154; Mean Difference (Final Values) -0.1 (95% CI -0.18 to -0.02) NCT02081391 ↗

Publications

• Background Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatr. 1984 Jun;104(6):849-54. doi: 10.1016/s0022-3476(84)80479-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tapentadol	Small molecule	0.1 mg/kg	Oral
Subject	Tapentadol	Small molecule	0.5 mg/kg	Oral
Subject	Tapentadol	Small molecule	1.25 mg/kg	Oral

Indications

No indication recorded.