Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)

Merck Sharp & Dohme LLC420 enrolled

Overview

Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

420

Conditions

Pain, Postoperative Arthroscopy

Interventions

MK0966 / Duration of Treatment: 1 DaysDRUG

Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 DaysDRUG

Comparator: placebo (unspecified) / Duration of Treatment: 1 DaysDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Elective outpatient arthroscopic knee surgery expected to last \<= 90 minutes using general anesthesia * Patients must experience moderate to severe pain following surgery * Patient must be in general good health as judged by the primary investigator Exclusion Criteria: * Osteoarthritis; rheumatoid arthritis * Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen * Asthma associated with nasal polyps * Any arthroscopic knee surgery in the past 6 months

Outcomes

Primary Outcomes

Total Pain Relief over 6 hours following a single oral dose compared to placebo.

Time frame: 6 hours

Secondary Outcomes

Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.

Time frame: 6 hours

Data from ClinicalTrials.gov

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