A Phase 4 interventional study of Zaldiar and Paracetamol-Tramadol in Pain, sponsored by Astes. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by Astes · Phase 4, Interventional, and Treatment
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).
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.
Astes is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Postoperative Analgesia with Zaldiar
Drug: Zaldiar
Postoperative Analgesia with Paracetamol-Tramadol
Drug: Paracetamol-Tramadol
Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
Also known as: Oral Zaldiar
Postoperative analgesia with intravenous Paracetamol and Tramadol
Also known as: Intravenous Paracetamol and Tramadol
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.
Time frame: In recovery room
| Milestone | Group Z | Group PT |
|---|---|---|
| Started | 24 | 27 |
| Completed | 24 | 27 |
| Not completed | 0 | 0 |
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.
| units on a scale | Group Z | Group PT |
|---|---|---|
| Acute Pain | 1.5 ± 1.28 | 1.74 ± 1.86 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group Z | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Group PT | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Categorical(Participants) | Group Z | Group PT | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 20 | 34 |
| >=65 years | 10 | 7 | 17 |
| Age, Continuous(years) | Group Z | Group PT | Total |
|---|---|---|---|
| Mean | 57.08 ± 16.42 | 62.41 ± 14.51 | 57.19 ± 15.29 |
| Sex: Female, Male(Participants) | Group Z | Group PT | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 21 | 24 | 45 |
| Region of Enrollment(participants) | Group Z | Group PT | Total |
|---|---|---|---|
| Belgium | 24 | 27 | 51 |
No study locations are listed for this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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