A Phase 2 interventional study of Metamizole in Children, Pain and Surgery, sponsored by University Children's Hospital Basel. Completed at 1 site in Switzerland. Open to participants aged 3 Months to 72 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by University Children's Hospital Basel · Phase 2, Interventional, and Other
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.
This is an open-label pharmacokinetics (PK) study. It aims to assess the PK parameters of metamizole and its metabolites following a single IV administration of metamizole (10mg/kg) in children less than 6 years of age.
Thirty-nine children, 3-72 months of age, undergoing elective surgery at the University of Basel Children's Hospital, will receive, on the day of surgical procedure, a single dose of metamizole 10 mg/kg. After this dose, blood and saliva samples will be obtained at predetermined post-dose time points to measure concentrations of metamizole and its metabolites. The maximal duration of subject participation will be 24 hours. Plasma PK parameters (AUC, Cmax, Tmax, t1/2) of each analyte will be derived using noncompartmental methods. A population PK approach will be applied to characterize inter-subject variability and quantify the potential influence of age, sex and body weight on the PK parameters.
There are no published pharmacokinetic studies of metamizole in pediatrics. Furthermore, although Swissmedic provides no dose information for IV administration in infants with a body weight of less than 9 kg, IV is the most frequently used route of administration for direct postoperative analgesia in pediatrics, including infants with body weights of less than 9 kg. Due to the absence of data and the lack of any dosing recommendation for infants with a body weight less than 9 kg, the IV administration of metamizole in infants is "off-label" and inconsistent across hospitals and prescribing paediatricians.
University Children's Hospital Basel is the lead sponsor of 27 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single IV metamizole (10mg/kg) administration
Drug: Metamizole
metamizole IV administration
Also known as: Novalgin
Area under the plasma concentration-time curves (AUC0-inf, AUC0-24, AUC0-last) for metamizole and its metabolites in plasma and saliva
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10 and 24 hours after single IV metamizole dose.
Time frame: 0- 24 hours
Maximum plasma concentration (Cmax) for metamizole and its metabolites in plasma and saliva
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10
Time frame: 0- 24 hours
Time to reach Cmax (tmax) for metamizole and its metabolites in plasma and saliva
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10
Time frame: 0- 24 hours
Terminal elimination rate constant with respective half-life time (t½) for metamizole and its metabolites in plasma and saliva
Time points of evaluation of these PK parameters: sampling at 1, 2, 4, 6, 10
Time frame: 0- 24 hours
Incidence of adverse events (AEs)
Time frame: 0- 24 hours
Correlation between metamizole and its metabolites in saliva and plasma
Time frame: 0- 24 hours
Plan to share: No
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Children's Hospital Basel