Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404177
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-07-03
Brief Title:
Enantyum IV Versus Piroxen IM in Emergency Pain Management
Sponsor:
Riadh Boukef
Organization:
Hôpital Universitaire Sahloul
Study Overview
Official Title:
Dexketoprofen IV Versus Piroxicam IM in Emergency Pain Management
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PiDex
Brief Summary:
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
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
Detailed Description:
This was a prospective randomized double-blind controlled study conducted at the Sahloul emergency department Sousse
Study duration 3 months
Inclusion criteria
Patients over 18 years of age requiring analgesia for acute pain of traumatic origin and who signed a written consent form were included in this 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
Methodology
1 Dexketoprofen group Patient receives an intravenous injection of Dexketoprofen IM placebo follow-up sheet appointment card
2 Piroxican group Patients receive one intramuscular Piroxen injection IV SSI infusion follow-up sheet appointment card
For each patient included VAS blood pressure heart rate respiratory rate and Sa02 are taken on admission and discharge from the emergency department and at the second telephone visit after 07 days
At the 7th day visit by telephone patients were asked to answer satisfaction questions and complete the EQ50 quality of life questionnaire
Study duration 3 months
Inclusion criteria
Patients over 18 years of age requiring analgesia for acute pain of traumatic origin and who signed a written consent form were included in this 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
Methodology
1 Dexketoprofen group Patient receives an intravenous injection of Dexketoprofen IM placebo follow-up sheet appointment card
2 Piroxican group Patients receive one intramuscular Piroxen injection IV SSI infusion follow-up sheet appointment card
For each patient included VAS blood pressure heart rate respiratory rate and Sa02 are taken on admission and discharge from the emergency department and at the second telephone visit after 07 days
At the 7th day visit by telephone patients were asked to answer satisfaction questions and complete the EQ50 quality of life questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None