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Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

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ClinicalTrials.gov Identifier: NCT02389361
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : August 13, 2015
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eric DEFLANDRE, MD, PhD, FCCP, 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).

Condition or disease Intervention/treatment Phase
Pain Drug: Zaldiar Drug: Paracetamol-Tramadol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: Group Z
Postoperative Analgesia with Zaldiar
Drug: Zaldiar
Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
Other Name: Oral Zaldiar

Active Comparator: Group PT
Postoperative Analgesia with Paracetamol-Tramadol
Drug: Paracetamol-Tramadol
Postoperative analgesia with intravenous Paracetamol and Tramadol
Other Name: Intravenous Paracetamol and Tramadol




Primary Outcome Measures :
  1. Acute Pain [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients incoming for inguinal hernia repair

Exclusion Criteria:

  • Preoperative abuse of analgesics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389361


Sponsors and Collaborators
Astes
Investigators
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Study Director: Eric Deflandre Astes

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Responsible Party: Eric DEFLANDRE, MD, PhD, FCCP, Eric DEFLANDRE, MD, FCCP, Astes
ClinicalTrials.gov Identifier: NCT02389361     History of Changes
Other Study ID Numbers: ASTES - ZIH
First Posted: March 17, 2015    Key Record Dates
Results First Posted: August 13, 2015
Last Update Posted: August 21, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants