Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Overview
- Phase
- Phase 3
- Intervention
- Naproxen
- Conditions
- Back Pain
- Sponsor
- EMS
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS).
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consent of the patient or legal guardian.
- •Men or women aged between 18 and
- •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
Arms & Interventions
Naproxen
Every 8 hours for 4 days.
Intervention: Naproxen
Ketorolac Tromethamine
Every 8 hours for 4 days
Intervention: Ketorolac Tromethamine
Outcomes
Primary Outcomes
Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS).
Time Frame: 4 days
The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit. The response rate is calculated using the following formula: Response rate = (VASvi - VASvf) / VASvi Considering: * VASvi: VAS in the first visit; * VASvf: VAS at the last visit;
Secondary Outcomes
- Safety will be evaluated by the adverse events occurrences(day 4)