Overview

Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

Status:
Completed
Trial end date:
2013-11-11
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
EMS
Treatments:
Ketorolac
Ketorolac Tromethamine
Naproxen
Criteria
Inclusion Criteria:

- Consent of the patient or legal guardian.

- Men or women aged between 18 and 65.

- Diagnosis of acute low back pain with moderate to severe pain (Visual Analog Scale
greater than 4 cm)

Exclusion Criteria:

- fracture confirmed by X-ray

- Diagnosis of infection, fever,

- Pregnancy, lactation;

- Diagnosis of fibromyalgia;

- Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or
other Nonsteroidal anti-inflammatory