Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain

Akdeniz University

Status and phase: Unknown; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Fastjel

Study type: Interventional

Funder types: Other

Identifiers

NCT02619695

2015/08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Ketoprofen

Experimental group

Description:

Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.

Treatment:

Drug: Fastjel

Placebo

Placebo Comparator group

Description:

Placebo arm: placebo gel form of ketoprofen

Treatment:

Drug: Fastjel