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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02491879
Enrollment
100
Registered
2015-07-08
Start date
2015-06-30
Completion date
2016-01-31
Last updated
2015-12-03

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

Conditions

Mechanical Low Back Pain

Keywords

mechanical low back pain, emergency department, ketoprofen, gel

Brief summary

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

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.

Interventions

DRUGKetoprofen

2.5% Ketoprofen gel with a 2 g local use

OTHERPlacebo

Placebo gel with a 2 g local use

Sponsors

Kocatepe University
CollaboratorOTHER
Celal Bayar 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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale30 minutesPain reduce will be measured by visual analogue scale score at 30 minutes

Secondary

MeasureTime frame
Adverse outcome30 minutes

Countries

Turkey (Türkiye)

Contacts

Primary ContactMustafa Serinken, MD
aserinken@hotmail.com00905052991497
Backup ContactCenker Eken, MD
cenkereken@akdeniz.edu.tr00905321593948

Outcome results

None listed

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