Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    160
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.
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.
Study Started
Jun 30
2015
Primary Completion
Jan 31
2016
Anticipated
Study Completion
Jan 31
2016
Anticipated
Last Update
Dec 02
2015
Estimate

Drug Fastjel

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

Ketoprofen Experimental

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

Placebo Placebo Comparator

Placebo arm: placebo gel form of ketoprofen

Criteria

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
No Results Posted