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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02619695
Enrollment
160
Registered
2015-12-02
Start date
2015-06-30
Completion date
2016-01-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

ketoprofen, gel, low back pain, emergency department

Brief summary

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

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.

Interventions

DRUGFastjel

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

Sponsors

Pamukkale University
CollaboratorOTHER
Celal Bayar University
CollaboratorOTHER
Kocatepe University
CollaboratorOTHER
Akdeniz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
visual analogue scale at 30 minutes30 minutes

Secondary

MeasureTime frame
Adverse effects30 minutes

Countries

Turkey (Türkiye)

Contacts

Primary ContactMustafa Serinken, Professor
aserinken@hotmail.com
Backup Contactaysel ozkan
karek@pau.edu.tr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026