Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain

Study Overview
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Brief Summary
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Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse effects.

Detailed Description
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Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs (NSAID) and paracetamol are used commonly in these patients. However, these drugs are not out of adverse effects and can not be used in some patients with diverse comorbidities. Gel forms of NSAIDs are used commonly in the outpatient clinics and shown to be effective in these patients by a Cochrane meta-analysis. However, there is no data on the effect of gel forms of analgesics in ED. The application of analgesics in gel forms might be a reasonable alternative to the paranteral drugs with fewer adverse effects. The present study aimed to reveal the effect of ketoprofen gel in patients presented with low back pain to emergency department.

Official Title
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Comparison of Ketoprofen Gel to Placebo in Patients Presented With Mechanical Low Back Pain to the Emergency Department: A Randomized Placebo Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Fastjel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanical low back pain Exclusion Criteria: Under 18 years old Over 65 years old Pain less than 40 mm in visual analogue scale Allergy to the study drug Drug or alcohol addiction Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketoprofen<br>Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area. | Drug: Fastjel<br>* 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.<br>|
| Placebo Comparator: Placebo<br>Placebo arm: placebo gel form of ketoprofen | Drug: Fastjel<br>* 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale at 30 minutes |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketoprofen, gel, low back pain, emergency department