Conditions: Pain
Keywords: Renal Colic Pain Urinary Tract Colic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 340
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.

Detailed description:

Arms:
arm 1: Ketoprofen plus placebo parecoxib arm 2: Parecoxib plus placebo ketoprofen

Interventions: intervention 1: Ketoprofen 100mg intervention 2: Parecoxib 40mg
Intervention descriptions: intervention 1: Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection intervention 2: Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period

Protocol document: