Pharmacokinetics of Intravenous Metamizole in Children Less Than 6 Years Old

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children

NCT07024199

Pancreatitis, Acute Pain, Acute Pancreatic Disease +4 more

RECRUITING PHASE4

Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.

NCT03912090

Acute Pain

COMPLETED

Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

NCT04278625

Congenital Heart Disease

COMPLETED

Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients

NCT00493246

Pain Fever

COMPLETED PHASE1

A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients

NCT01635101

Acute Pain

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children Pain Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

metamizole

single IV metamizole (10mg/kg) administration

Group Type EXPERIMENTAL

Metamizole

Intervention Type DRUG

metamizole IV administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metamizole

metamizole IV administration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Novalgin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes