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Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

NCT ID: NCT02389361

Last Updated: 2018-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Group Z

Postoperative Analgesia with Zaldiar

Group Type EXPERIMENTAL

Zaldiar

Intervention Type DRUG

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

Group PT

Postoperative Analgesia with Paracetamol-Tramadol

Group Type ACTIVE_COMPARATOR

Paracetamol-Tramadol

Intervention Type DRUG

Postoperative analgesia with intravenous Paracetamol and Tramadol

Interventions

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Zaldiar

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

Intervention Type DRUG

Paracetamol-Tramadol

Postoperative analgesia with intravenous Paracetamol and Tramadol

Intervention Type DRUG

Other Intervention Names

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Oral Zaldiar Intravenous Paracetamol and Tramadol

Eligibility Criteria

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Inclusion Criteria

* All patients incoming for inguinal hernia repair

Exclusion Criteria

* Preoperative abuse of analgesics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astes

OTHER

Sponsor Role lead

Responsible Party

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Eric DEFLANDRE, MD, PhD, FCCP

Eric DEFLANDRE, MD, FCCP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Deflandre

Role: STUDY_DIRECTOR

Astes

Other Identifiers

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ASTES - ZIH

Identifier Type: -

Identifier Source: org_study_id

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