Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05054023 |
Other study ID # |
Topic analgesics |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
October 21, 2021 |
Est. completion date |
March 21, 2022 |
Study information
Verified date |
June 2022 |
Source |
University of Monastir |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Acute soft tissues injuries are a common complaint for emergency department (ED) visit. RICE
and Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain
and inflammation. Herbal therapy is commonly used to treat pain but few studies assessed its
efficacy and tolerability.
Description:
Materials and methods :
Study design It is a randomized, prospective, double blind, controlled, multicentric trial.
Study setting and selection of participants :
The trial is conducted in three community teaching hospitals :
- Emergency department, fattouma bourgiba university hospital, monastir, tunisia.
- Emergency department, sahloul university hospital, sousse, tunisia.
- Emergency department, farhat hached university hospital, sousse, tunisia.
The study includes patients aged 18 to 60 years who presented to the ED with acute
soft-tissues limb trauma pain occurring within 24 hours before presentation, with a visual
numeric scale (VNS) of 5 or more on a standard 11 point (0-10) and who required a
prescription for home use analgesic treatment upon discharge. An informed consent is
necessary. Pain was considered traumatic if it is reported as appearing immediately after the
trauma.
Protocol :
After medical evaluation, every patient who meet the inclusion criteria, will receive
randomly either Piroxicam gel or Soulagel tubes as detailed above according to the
predetermined randomization.
None of the treating physician or nurses are aware about the medication received.
Adhesive and/or immobilizing casts, bandages, splints, and treatment by rest, ice,
compression, or elevation were prohibited after randomization.
Patients could not take additional medications such as oral NSAIDs, opioids, muscle
relaxants, or supplemental topical therapies.
Patients were phonelly contacted in order to ensure treatment adherence and evaluate VAS once
a day until the end of the treatment. After the end of the treatment, patients' satisfaction
with the treatment was noted and quoted as "not satisfied", "satisfied", and "very
satisfied".
Need for rescue analgesic treatment was noted as well as the dose and duration. All patients
were encouraged to report all adverse events during the treatment period. S
All data recorded on data collection sheets, including sex, demographics, medical history,
and vital signs, were entered into SPSS (version 20.0 ; IBM corps) by the research manager.
Patients's informed consent is obtained. The ethic commitee of our institution approved the
study.