i.v. tapentadol for the treatment of post-surgical pain in children
Research type
Research Study
Full title
Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of tapentadol intravenous solution for the treatment of post-surgical pain in children aged from birth to less than 2 years, including preterm neonates.
IRAS ID
160993
Contact name
Ayman Eissa
Contact email
Sponsor organisation
Grunenthal
Eudract number
2014-002259-24
Clinicaltrials.gov Identifier
U1111-1157-3228, WHO Universal Trial Number (UTN)
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This trial evaluates a pain medication called tapentadol solution for injection for use in children to reduce pain after surgery. Tapentadol oral solution has currently been approved in a number of countries for the treatment of acute pain in adults. The study will look at the effects of tapentadol solution for injection in young children aged between birth and less than 2 years old including preterm neonates, with acute pain following surgery.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1269
Date of REC Opinion
23 Jan 2015
REC opinion
Further Information Favourable Opinion