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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Zaldiar
Drug: Paracetamol-Tramadol
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group Z Group PT
Hide Arm/Group Description

Postoperative Analgesia with Zaldiar

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

Postoperative Analgesia with Paracetamol-Tramadol

Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol

Period Title: Overall Study
Started 24 27
Completed 24 27
Not Completed 0 0
Arm/Group Title Group Z Group PT Total
Hide Arm/Group Description

Postoperative Analgesia with Zaldiar

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

Postoperative Analgesia with Paracetamol-Tramadol

Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol

Total of all reporting groups
Overall Number of Baseline Participants 24 27 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  58.3%
20
  74.1%
34
  66.7%
>=65 years
10
  41.7%
7
  25.9%
17
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 27 participants 51 participants
57.08  (16.42) 62.41  (14.51) 57.19  (15.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Female
3
  12.5%
3
  11.1%
6
  11.8%
Male
21
  87.5%
24
  88.9%
45
  88.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Belgium Number Analyzed 24 participants 27 participants 51 participants
24 27 51
1.Primary Outcome
Title Acute Pain
Hide Description 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.
Time Frame In recovery room
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group Z Group PT
Hide Arm/Group Description:

Postoperative Analgesia with Zaldiar

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

Postoperative Analgesia with Paracetamol-Tramadol

Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol

Overall Number of Participants Analyzed 24 27
Median (Standard Deviation)
Unit of Measure: units on a scale
1.5  (1.28) 1.74  (1.86)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group Z Group PT
Hide Arm/Group Description

Postoperative Analgesia with Zaldiar

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

Postoperative Analgesia with Paracetamol-Tramadol

Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol

All-Cause Mortality
Group Z Group PT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group Z Group PT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group Z Group PT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. DEFLANDRE Eric
Organization: ASTES
Phone: 0032477764241
Responsible Party: Eric DEFLANDRE, MD, PhD, FCCP, Astes
ClinicalTrials.gov Identifier: NCT02389361     History of Changes
Other Study ID Numbers: ASTES - ZIH
First Submitted: February 27, 2015
First Posted: March 17, 2015
Results First Submitted: June 22, 2015
Results First Posted: August 13, 2015
Last Update Posted: August 21, 2018