Conditions: Bunion Pain
Keywords: Bunionectomy Postsurgical Pain Acute Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 177
Healthy volunteers: no

Brief summary:
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.

Detailed description:

Arms:
arm 1: Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone. arm 2: Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.

Interventions: intervention 1: Tapentadol intervention 2: Matching Placebo
Intervention descriptions: intervention 1: 30 mg per administration, maximum 12 administrations over 48 hours intervention 2: Maximum 12 administrations over 48 hours

Protocol document: