Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two
 different drugs in the treatment of patients diagnosed with moderate to severe back pain
 treatment.
-  double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to
 treat trial.

 -  Experiment duration: 04 days.

 -  03 visits (days 0, 2 and 4).

 -  Efficacy will be evaluated for back pain relief based on visual analogic scale.

 -  Adverse events evaluation.
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 Analogic score
 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