Pharmacokinetic study of the opioid ketobemidone in children and adolescens after intravenous administration

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006717-32-SE

Enrollment

Registered

2006-12-11

Start date

2007-01-31

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain treatment with opioids in children

Interventions

Trade Name: Ketogan Novum Product Name: Ketogan Novum Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of elimination half life of ketobemidone after intravenous injection in children;Secondary Objective: ;Primary end point(s): Plasma concentration of ketobemidone	—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026