Comparative Prospective Randomized Study in Postoperative Cardiac Surgery Patients on Analgesia with Morphine Continuous Infusion or Sublingual Sufentanil (Zalviso®).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004038-28-BE

Enrollment

Registered

2017-12-08

Start date

2018-02-21

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: MORPHINE HCl STEROP Product Name: Morphine Product Code: BE414346 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: MORPHINE CAS Number: 57-27-2 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All postoperative cardiac surgery patients aged between 18-75 y Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: -Patients with known allergy -Patients with allergy to opioid drugs or a medical history of psychiatric disease --Patients with chronic inflammatory disease or chronic obstructive lung disease -Pregnancy in female subjects in child-bearing age -Body mass index greater than 35 kg/m2 -Participation in another clinical trial -Drug abuse -Psychological or emotional problems -The use of nonsteroidal anti-inflammatory drugs or monoamine oxidase inhibitors -Pain therapy with opioids 14 days before the start of the study -Patients who are not cooperative or could not use PCA will be also excluded. -All patients who cannot be weaned from the ventilator the day of surgery or the first postoperative day will be excluded -Patients who are delirious or to whom no communication could be performed.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): -Nausea, vomiting and constipation -Pruritus -Consciousness;Timepoint(s) of evaluation of this end point: twice daily	—

Primary

Measure	Time frame
Main Objective: The present study aims to assess postoperative pain after cardiac surgery by means of a standardized scoring system.;Secondary Objective: -Presence of nausea, vomiting, constipation -Pruritus -Consciousness;Primary end point(s): VAS score;Timepoint(s) of evaluation of this end point: twice daily	—

Countries

Belgium

Contacts

Public ContactVeerle Van Mossevelde

Universitair Ziekenhuis Brussel

veerle.vanmossevelde@uzbrussel.be+3224763134

Outcome results