Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge

Acute Pain Clinical Trial

— TPS  

Official title:

Randomized Clinical Trial of Topical Piroxicam Versus a New Herbal Medicine Based Gel in the Treatment of Acute Extremity Pain After Emergency Department Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054023
• Other study ID #: Topic analgesics
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1525
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients who presented to the ED with acute non-penetrating minor soft tissues musculoskeletal limb trauma occurring within 24 hours before presentation, and who required a prescription for home use analgesic treatment upon discharge for pain-on-movement (POM) with intensity >50 on a visual numeric scale (VNS) on a standard 11 point (0-10).
• Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.

Exclusion Criteria:

• Pregnancy/Breastfeeding
• Skin lesions (excessive dryness or redness of the skin, atopic dermatitis, and eczema) in the painful region
• Presence of wound, joint dislocation, or more than one injury
• Presence of a fracture
• Severe trauma (ISS > 16)
• Hospitalization or surgery, daily use of NSAIDs or other analgesia within 2 weeks
• Previous treatment with analgesia for the same injury
• History of previous adverse reaction or known allergy or hypersensitivity
• Physical, visual, or cognitive impairment (inability to use the VNS pain score)
• Refusal to consent or to communicate

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Intervention

Drug:
• Soulagel®
topic gel
• Arthrosyl®
topic gel

Locations

Country	Name	City	State
Tunisia	Nouira Samir	Monastir	Emergency Department Monastir, Tunisia 5000

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success resolution of pain with decrease of VAS more than 50% comparing to initial value at 30 minutes following analgesia administration	resolution of pain with decrease of visual numeric scale (that range from 0: no pain to 10 :severe pain) more than 50% comparing to initial value	at seven days post ED discharge
Primary	Occurence of severe adverse events	occurence of severe adverse events	at seven days post ED discharge
Secondary	Pain resolution time	time between the start of the analgesic treatment and the one when VNS (that range from 0: no pain to 10 :severe pain) decreased to less than 3.	at seven days post ED discharge
Secondary	The need for rescue analgesia and	doses of morphine required to reach efficient analgesia	at seven days post ED discharge
Secondary	Patient Satisfaction	Satisfaction of patients evaluated with the likert score at the ED discharge. (at 120 minutes patients were asked to rate the severity of nasal irritation on a 1 to 10 ordinal scale anchored.	at seven days post ED discharge