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Generation of a model for the adaption of the postoperative pain therapy with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used

Conditions
Pain therapy after elective cardiac surgery
MedDRA version: 14.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2011-003648-31-DE
Lead Sponsor
niversitätsklinikum Erlangen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Written informed consent
Ability to understand the nature of patient-controlled analgesia and other study-specific procedures
Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Use of MAO inhibitors in the last 14 days
Chronic alcoholism or drug addiction in medical history
Severe obstuctive or restrictive pulmonal disorders in medical history
Severe hepatic and renal disorders in medical history
Hypothyroidism, prostate hyperplasia, pancreatitis, biliary or renal colic in medical history
ASA IV
Pregnant or nursing females

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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