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

Back Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Back Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ketorolac Tromethamine10 drops each 8 hours for 4 days.

Drug:Naproxen2 tablets every 8 hours for 4 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Naproxen2 tablets every 8 hours for 4 days.

Ketorolac Tromethamine10 drops every 8 hours for 4 days

Study Status

Unknown status

Start Date: October 2013

Completed Date: September 2014

Phase: Phase 3

Type: Interventional


Primary Outcome: Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).

Secondary Outcome: Safety will be evaluated by the adverse events occurrences

Study sponsors, principal investigator, and references

Principal Investigator: PĂ©rola Plaper, MD

Lead Sponsor: EMS


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