EUCTR2014-004088-19-DE
Active, not recruiting
Phase 1
Postoperative pain treatment after elective cardiac surgery using patient-controlled target-controlled infusion (TCI-PCA) with hydromorphone vs. patient-controlled analgesia (PCA) with morphine - TCI-PCA Hydromorphon vs. PCA Morphin
niversitätsklinikum Erlangen0 sitesNovember 20, 2014
ConditionsPostoperative pain treatment after elective cardiac surgeryMedDRA version: 18.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsPalladon
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Postoperative pain treatment after elective cardiac surgery
- Sponsor
- niversitätsklinikum Erlangen
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent.
- •Age between 40 and 85 years, both genders.
- •Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay.
- •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 20
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Administration of other analgesics or sedatives, if not administered in stable dosage for at least 14 days or if not used for premedication and surgery.
- •Administration of hydromorphone or morphine in the period between secreening and admission to the ICU.
- •Severe hepatic or renal impairment in medical history.
- •BMI \=35 kg/m².
Outcomes
Primary Outcomes
Not specified
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