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NCT02389361 Clinical Trial

Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02389361
Other study ID # ASTES - ZIH
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2011
Est. completion date October 2011

Study information
Verified date July 2018
Source Astes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date October 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients incoming for inguinal hernia repair

Exclusion Criteria:

- Preoperative abuse of analgesics

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zaldiar
Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
• Paracetamol-Tramadol
Postoperative analgesia with intravenous Paracetamol and Tramadol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astes

Outcome
Type Measure Description Time frame Safety issue
Primary 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. In recovery room
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