Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study
Research type
Research Study
Full title
Analgesic efficacy of oral dexketoprofen trometamol/tramadol hydrochloride versus tramadol hydrochloride/paracetamol: a randomised, double-blind, placebo and active controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar.
IRAS ID
195903
Contact name
Thomas Dietrich
Contact email
Sponsor organisation
MENARINI RICERCHE S.p.A.
Eudract number
2015-004152-22
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Pain is the most common symptom that patients seek medical advice for. Management of pain continues to be inadequate despite the great variety of analgesics (pain killers) available. This is due to the difficult diagnosis of the pain and fear of the side effects. Moderate to severe pain relief is difficult to achieve using one medication so two are commonly combined, however combinations are often used without knowledge of the interaction and/ or best dose for the optimum effect.
The aim of the study is to evaluate how effective Dexketoprofen trometamol (DKP) and Tramadol hydrochloride (TRAM) fixed dose is on moderate to severe pain. DKP and TRAM are well known and used medications, often prescribed together. DKP works fast on mild to moderate pain and TRAM works more slowly but for a longer period on moderate to severe pain.
In this study the DKP/TRAM fixed dose combination will be compared to a placebo (dummy pill) and a control medication of TRAM/ Paracetamol.
If participants experience significant pain following surgical removal of an impacted lower third molar tooth, they will be randomised to the study medication, the control or the placebo for one dose. For the 8 hours following the dosing, participants will be asked to record the intensity of their pain using an 11 point scale, the experienced pain relief through a 5-point scale and an overall judgement on the treatment received using a 5-point scale on an electronic e-dairy. Rescue medication is available for participants who do not achieve suitable pain relief.
The participants will be required to attend at least 3 visits to the study site and their participation is expected to last from a minimum of 7 days to a maximum of 3 weeks.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0024
Date of REC Opinion
1 Mar 2016
REC opinion
Further Information Favourable Opinion