Ketoprofen Gel vs Placebo in Low Back Pain

Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Mechanical Low Back Pain
• Intervention / Treatment: Drug: Ketoprofen; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Recruiting
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketoprofen; Ketoprofen gel	Drug: Ketoprofen; 2.5% Ketoprofen gel with a 2 g local use; Other Names: Fastjel
Placebo Comparator: Placebo; Placebo form of ketoprofen gel	Other: Placebo; Placebo gel with a 2 g local use; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Pain reduce will be measured by visual analogue scale score at 30 minutes	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse outcome	30 minutes

Collaborators and Investigators

• Sponsor: Akdeniz University
• Collaborators: Celal Bayar University; Kocatepe University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: July 3, 2015
• First Submitted That Met QC Criteria: July 3, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: emergency department; mechanical low back pain; ketoprofen; gel
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: 24924

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No