Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Paracetamol-Tramadol; Drug: Zaldiar

• Registration Number: NCT02389361
• Lead Sponsor: Astes

Brief Summary

Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).

Detailed Description

Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Results First Submitted: 2015-06-22
• Results First Submitted QC: 2015-07-18
• Results First Posted: 2015-08-13
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• All patients incoming for inguinal hernia repair

Exclusion Criteria

• Preoperative abuse of analgesics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group PT	Paracetamol-Tramadol	Postoperative Analgesia with Paracetamol-Tramadol
Group Z	Zaldiar	Postoperative Analgesia with Zaldiar

Primary Outcome Measures

Name	Time	Method
Acute Pain	In recovery room	Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS \> 4. The VAS use units on a scale.