Pharmacokinetics of Intravenous Metamizole in Children Less Than 6 Years Old

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the PK parameters of metamizole following a single IV administration of metamizole in children less than 6 years of age.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Children's Hospital Basel
• Treatments: Dipyrone

Criteria

Inclusion Criteria:

• Infants and children 3-72 months of age at time of inclusion

• Body weight more than 5 kg at time of inclusion

• Children undergoing elective surgery at University of Basel Children's Hospital (UKBB) with planned administration of intravenous analgesia

• Patients who require surgical procedures that necessitate at least 24 hours in the hospital

• Parent/Legal guardian has been informed about the study and has signed Informed Consent Form

Exclusion Criteria:

• Infants and children who were born prematurely (before 37 weeks gestation), regardless of corrected gestational age

• Known kidney or liver disease

• Known neutropenia, anemia or other hematological disorders

• Known diagnosis of asthma

• Ongoing immunosuppression, except corticosteroid treatment, or primary immunodeficiency

• Treatment with strong inhibitors or inducers of CYP2C19 within 3 months prior to study

• Treatment with drugs known to induce agranulocytosis within 3 months prior to study

• Documented previous adverse reaction to metamizole

• Treatment with metamizole within 30 days prior to screening

• Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study

• Family members of investigators