FindTrial
Sign In

Pharmacokinetic study of the opioid ketobemidone in neonates after an intravenous administration

Pharmacokinetic study of the opioid ketobemidone in neonates after an intravenous administration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-008012-98-SE
Enrollment
Unknown
Registered
2009-10-22
Start date
2009-12-18
Completion date
Unknown
Last updated
2012-05-29

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*

Sponsors

Stefan Lundeberg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Determination of pharmacokinetic parameters of ketobemidone after an intravenous injection;Secondary Objective: None;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