Pharmacokinetic study of the opioid ketobemidone in neonates after an intravenous administratio
- Conditions
- Pain treatment with opioids in children
- Registration Number
- EUCTR2008-008012-98-SE
- Lead Sponsor
- Stefan Lundeberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Neonates undergoing painful procedure that requires analgesic treatment with opioids. ASA class 1 and 2. Signed informed consent from parents/caregivers.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
ASA class 3 and 4. Liverdisease or dysfunction. Predicted blood loss >10% of total blood volume. Patients with known allergy or sensitivity to the test drug. Individuals not giving consent to participate in the study.
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