Pharmacokinetic study of the opioid ketobemidone in children and adolescens after intravenous administratio
- Conditions
- Pain treatment with opioids in children
- Registration Number
- EUCTR2006-006717-32-SE
- Lead Sponsor
- Stefan Lundeberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Children less than 15 years of age ( 3 age groups) undergoing painful procedure that requires analgesic treatment with opioids. ASA class I and II. Signed informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
ASA class III and IV. Liverdisease or liver dysfunction. Predicted blood loss > 10 % of blood volume. Patient 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 Main Objective: Determination of elimination half life of ketobemidone after intravenous injection in children;Secondary Objective: ;Primary end point(s): Plasma concentration of ketobemidone
- Secondary Outcome Measures
Name Time Method