Quality of postoperative pain control and incidence and severity of nausea, vomiting, constipation, sedation, vertigo and somnolence during the treatment of postoperative pain with Palexia® compared to Targin®.
- Conditions
- Management of postoperative pain in trauma surgery patients (adults) requiring postoperative opiates for the management of postoperative pain.MedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865Therapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
- Registration Number
- EUCTR2011-003238-15-DE
- Lead Sponsor
- KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 266
Adult trauma patients ASA I-III requiring postoperative opiates for the management of pain
Surgical treatment required
Age > 18 Years
Subjects must have signed an informed consent form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it
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 166
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Patients unable to give informed consent
Pregnant or breast-feeding women
Pre- existing chronic pain treated with opiates
Severe renal or hepatic impairment
Treatment with MAO- inhibitors
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method