Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy

POZEN100 enrolled

Overview

To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Bunionectomy Orthopedic Surgery

Interventions

Lornoxicam 8 mgDRUG

Lornoxicam 16 mgDRUG

Ketorolac 30 mgDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic. * Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications. * Subjects are in generally good health with no uncontrolled chronic illnesses or diseases. Exclusion Criteria: * Subjects who are pregnant. * Subjects who have significant obesity. * Subjects with medically significant heart, liver, kidney, lung or endocrine disease. * Subjects with active viral disease, i.e. hepatitis, HIV.

Locations (1)

Advanced Clinical Research Institute

Anaheim, California, United States

Outcomes

Primary Outcomes

The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy)

To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.

Secondary Outcomes

To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.

Data from ClinicalTrials.gov

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