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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

Tracking Information
First Submitted Date  ICMJE February 27, 2015
First Posted Date  ICMJE March 17, 2015
Results First Submitted Date  ICMJE June 22, 2015
Results First Posted Date  ICMJE August 13, 2015
Last Update Posted Date August 21, 2018
Study Start Date  ICMJE April 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
Acute Pain [ Time Frame: In recovery room ]
Difference between groups in term of analgesia (as measured by Visual Analog Scale)
Change History Complete list of historical versions of study NCT02389361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
Neuropathic Pain [ Time Frame: at 6 months ]
Difference between groups in term of neuropathic pain (as measured by the DN4 score)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol
Official Title  ICMJE ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Zaldiar
    Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
    Other Name: Oral Zaldiar
  • Drug: Paracetamol-Tramadol
    Postoperative analgesia with intravenous Paracetamol and Tramadol
    Other Name: Intravenous Paracetamol and Tramadol
Study Arms  ICMJE
  • Experimental: Group Z
    Postoperative Analgesia with Zaldiar
    Intervention: Drug: Zaldiar
  • Active Comparator: Group PT
    Postoperative Analgesia with Paracetamol-Tramadol
    Intervention: Drug: Paracetamol-Tramadol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2015)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients incoming for inguinal hernia repair

Exclusion Criteria:

  • Preoperative abuse of analgesics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02389361
Other Study ID Numbers  ICMJE ASTES - ZIH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric DEFLANDRE, MD, PhD, FCCP, Astes
Study Sponsor  ICMJE Astes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Deflandre Astes
PRS Account Astes
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP