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 oral solution for the treatment of post-surgical pain in children aged from birth to less than 2 years
IRAS ID
159820
Contact name
Ayman Eissa
Contact email
Sponsor organisation
Grünenthal GmbH
Eudract number
2014-000623-24
Clinicaltrials.gov Identifier
U1111-1153-1662, WHO Universal Trial Number (UTN); R331333PAI2007, Janssen Research & Development LLC
Research summary
This trial evaluates a pain medication called tapentadol oral solution for use in children to reduce pain after surgery. An oral solution means that the medication is a liquid that can be taken by mouth. 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 oral solution in young children aged between birth and less than 2 years old with acute pain following surgery.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1165
Date of REC Opinion
30 Oct 2014
REC opinion
Further Information Favourable Opinion