Trial Outcomes & Findings for Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol (NCT NCT02389361)

NCT ID: NCT02389361

Last Updated: 2018-08-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: In recovery room
• Results posted on: 2018-08-21

Participant Flow

Participant milestones

Measure	Group Z Postoperative Analgesia with Zaldiar Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)	Group PT Postoperative Analgesia with Paracetamol-Tramadol Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol
Overall Study STARTED	24	27
Overall Study COMPLETED	24	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

Baseline characteristics by cohort

Measure	Group Z n=24 Participants Postoperative Analgesia with Zaldiar Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)	Group PT n=27 Participants Postoperative Analgesia with Paracetamol-Tramadol Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	57.08 years STANDARD_DEVIATION 16.42 • n=5 Participants	62.41 years STANDARD_DEVIATION 14.51 • n=7 Participants	57.19 years STANDARD_DEVIATION 15.29 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment Belgium	24 participants n=5 Participants	27 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Group Z n=24 Participants Postoperative Analgesia with Zaldiar Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)	Group PT n=27 Participants Postoperative Analgesia with Paracetamol-Tramadol Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol
Acute Pain	1.5 units on a scale Standard Deviation 1.28	1.74 units on a scale Standard Deviation 1.86

Adverse Events

Group Z

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group PT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. DEFLANDRE Eric

ASTES

Phone: 0032477764241

Email: eric.deflandre@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place