Clinical trial
Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management
Name
Dexketoprofene-Piroxicam
Description
For pain of traumatic origin, the RICE protocol (Rest, Ice, Compression, Elevation) is the main therapeutic measure during the first 4 to 5 days post-trauma. However, there is currently insufficient evidence that this protocol is effective \[4\].
In the emergency department, paracetamol, NSAIDs or a combination of several molecules are generally prescribed. Patients even use these drugs without a prescription.
The aim of this study is to Compare the effect of dexketoprofen® IV versus piroxen® IM in the treatment of pain in emergency departments.
Trial arms
Trial start
2023-07-15
Estimated PCD
2024-08-01
Trial end
2024-08-30
Status
Recruiting
Phase
Early phase I
Treatment
Dexketoprofen
An intravenous perfusion of eunantyum with an intramuscular isotonic saline
Arms:
Dexketoprofen
Other names:
Placebo IM
Piroxicam
intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous
Arms:
Piroxicam
Other names:
placebo IV
Size
300
Primary endpoint
Time to pain resolution
120 minutes
Eligibility criteria
Inclusion Criteria:
* Patients over 18 years of age who required analgesia for acute pain of traumatic origin and who signed a written consent form were included in the study.
Exclusion Criteria:
* Patients who meet the following conditions:
* refusal, incapacity, difficulties with consent or communication
* Patients with chronic pain.
* Any known allergy or secondary reaction to piroxen or dexketoprofen trometamol.
* Pregnant women.
* Cirrhosis of the liver.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomised , double blind controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-05-08
1 organization
2 products
1 indication
Organization
Riadh BoukefProduct
DexketoprofenIndication
TraumaProduct
Piroxicam