Conditions: Post Operative Dental Pain
Keywords: Diclofenac potassium Post-operative dental pain Moderate to severe pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 328
Healthy volunteers: no

Brief summary:
The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.

Detailed description:

Arms:
arm 1: Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method. arm 2: Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.

Interventions: intervention 1: Diclofenac potassium intervention 2: Ibuprofen intervention 3: Placebo to ibuprofen intervention 4: Placebo to diclofenac potassium
Intervention descriptions: intervention 1: Single dose of diclofenac 50 mg soft gelatin capsule intervention 2: Single dose of ibuprofen 400 mg tablet intervention 3: Single dose of placebo to ibuprofen 400 mg tablet intervention 4: Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule

Protocol document: