Title

Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol
ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Indication/Condition

    Pain
  • Study Participants

    51
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).
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 Started
Apr 30
2011
Primary Completion
Sep 30
2011
Study Completion
Oct 31
2011
Results Posted
Aug 13
2015
Estimate
Last Update
Aug 21
2018

Drug Zaldiar

Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)

  • Other names: Oral Zaldiar

Drug Paracetamol-Tramadol

Postoperative analgesia with intravenous Paracetamol and Tramadol

  • Other names: Intravenous Paracetamol and Tramadol

Group Z Experimental

Postoperative Analgesia with Zaldiar

Group PT Active Comparator

Postoperative Analgesia with Paracetamol-Tramadol

Criteria

Inclusion Criteria:

All patients incoming for inguinal hernia repair

Exclusion Criteria:

Preoperative abuse of analgesics

Summary

Group Z

Group PT

All Events

Event Type Organ System Event Term

Acute Pain

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.

Group Z

1.5
units on a scale (Median)
Standard Deviation: 1.28

Group PT

1.74
units on a scale (Median)
Standard Deviation: 1.86

Total

51
Participants

Age, Continuous

57.19
years (Mean)
Standard Deviation: 15.29

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Group Z

Group PT