Enantyum® IV Versus Piroxen® IM in Emergency Pain Management | NCT06404177

Studies
Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

NCT06404177

Sponsor

Riadh Boukef

Status

Unknown status

Last Update Posted

May 8, 2024Actual

Enrollment

300Estimated

Phase

Phase 3

Conditions

Traumatic Injury

Interventions

Dexketoprofen
Piroxicam

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2023Actual

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Aug 30, 2024Estimated

First Submitted Date

Jul 3, 2023

First Submission Date that Met QC Criteria

May 4, 2024

First Posted Date

May 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2024

Last Update Posted Date

May 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Riadh Boukef, professor, Hôpital Universitaire SahloulSponsor-Investigator

Lead Sponsor

Riadh BoukefOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

Dexketoprofen group Patient receives an intravenous injection of Dexketoprofen + IM placebo + follow-up sheet + appointment card.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexketoprofen	Experimental	Patients receive a perfusion of Dexketoprofen in intraveinous with an injection of istonic saline IM injection	Drug: Dexketoprofen
Piroxicam	Active Comparator	Patients receive an intramuscular injection of piroxicam with an intravenous isotonic saline	Drug: Piroxicam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexketoprofen	Drug	An intravenous perfusion of eunantyum with an intramuscular isotonic saline	Dexketoprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to pain resolution	VAS<3	120 minutes

Secondary Outcomes

Measure	Description	Time Frame
rescue tratment	rate of the use of another analgesics	120 minutes
Side effects	number of patients with epigastralgia , digestive bleeding, nausea, vomiting

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Riadh Boukef, professor	Contact	98676745	216	riadboukef@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahloul University Hospital	Recruiting	Sousse		5000	Tunisia

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C118296	dexketoprofen trometamol
D010894	Piroxicam

Ancestor Terms

ID	Term
D013843	Thiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided