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Ketoprofen Gel vs Placebo in Low Back Pain

A

Akdeniz University

Status and phase

Unknown
Phase 4

Conditions

Mechanical Low Back Pain

Treatments

Other: Placebo
Drug: Ketoprofen

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Full description

Mechanical low-back pain which warrants immediate pain relief is not an infrequent symptom for emergency department physicians to deal with. Parenteral analgesic is the most common drugs for the these patients in emergency department. However, pain killers in gel forms have not been studied sufficiently for ceasing the pain of these patients. This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients over 18 and lower 65 years old
  • Patients presented with mechanical low-back pain

Exclusion criteria

  • Pain more than 24 hours
  • Pain lower than with a pain score of 40 mm
  • Allergy to ketoprofen
  • Drug or alcohol addiction
  • pregnancy and breast feeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Ketoprofen
Experimental group
Description:
Ketoprofen gel
Treatment:
Drug: Ketoprofen
Placebo
Placebo Comparator group
Description:
Placebo form of ketoprofen gel
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Cenker Eken, MD; Mustafa Serinken, MD

Data sourced from clinicaltrials.gov

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