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

EMS

Status and phase: Completed; Phase 3

Conditions: Back Pain

Treatments: Drug: Naproxen; Drug: Ketorolac Tromethamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471886

CTREMS0611

Details and patient eligibility

About

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.

Full description

• 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 analog scale.
• Adverse events evaluation.

Enrollment: 83 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups

Naproxen

Active Comparator group

Description:

Every 8 hours for 4 days.

Treatment:

Drug: Naproxen

Ketorolac Tromethamine

Experimental group

Description:

Every 8 hours for 4 days

Treatment:

Drug: Ketorolac Tromethamine