ParacetamolTISSUENCT07585487
Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children
An observational study of Paracetamol and Cefazolin, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Pharmacokinetic evaluations will be conducted to characterize the cefazolin plasma concentration-time profile, cefazolin penetration into subcutaneous adipose tissue, and paracetamol metabolization as assessed through blood sampling. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Paracetamol, Cefazolin
- What is being tested?
- Cefazolin and Paracetamol (drug)
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Dec 2023to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing minor elective surgery at Ghent University Hospital
Who may be able to join
- Patient admitted to the operating room for minor elective surgery
- Patients undergoing general anesthesia for minor elective surgery
- Patient age: children from 2 years to 15 years
- Patients receiving cefazolin or paracetamol according to the standard procedure
- Intra-arterial (preferred) or intravenous access available for blood sampling
- BMI
Who cannot join
- Personal or family history of excessive bleeding
- Pre-existing coagulopathy and/or thrombocytopenia
- No catheter available for blood sampling
- Absence of parental consent
- Known allergy to one of the components of the study
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital, Ghent
Ghent, 9000
Anca Amza, +32 9 332 18 83, anca.amza@uzgent.be
Pieter De Cock, Prof. Apr.
About this study
Pharmacokinetic evaluations will be conducted to characterize the cefazolin plasma concentration-time profile, cefazolin penetration into subcutaneous adipose tissue, and paracetamol metabolization as assessed through blood sampling. The study population consists of children aged 2 to 15 years with either normal weight or overweight. All participants are admitted for a minor elective surgical procedure and will receive paracetamol and/or cefazolin as part of standard perioperative care.
During the procedure, multiple blood and tissue-fluid samples will be collected to quantify paracetamol and cefazolin concentrations in the bloodstream, as well as cefazolin concentrations in subcutaneous adipose tissue. The study aims to characterize drug concentration-time profiles in blood (paracetamol), plasma (cefazolin), and adipose tissue (cefazolin), and to compare these pharmacokinetic parameters between normal-weight and overweight children.
These data are essential to determine whether standard dosing regimens provide adequate drug exposure across different weight categories. Previous research indicates that achieving specific target concentrations in blood and tissue is necessary for optimal therapeutic effect, yet uncertainty remains regarding appropriate dosing in overweight children.
- Conditions
- Paracetamol, Cefazolin
- Being tested
- Cefazolin, Paracetamol (drug)
- Keywords
- Paracetamol, Cefazolin, Overweight, children
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Also called Cephazolin
Prophylactic Cefazolin treatment per standard-of-care
Paracetamol (drug)Drug
Also called Acetaminophen
Preoperative dose of paracetamol, as per standard-of-care
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Paracetamol or Cefazolin treatment in children with normal weight | Not described Receives: Drug: Cefazolin; Drug: Paracetamol (drug) | |
| Standard of Care Paracetamol or Cefazolin treatment in children with overweight | Not described Receives: Drug: Cefazolin; Drug: Paracetamol (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations of paracetamol and its metabolites
Blood concentrations (mg/L) of paracetamol and its metabolites: glucuronide-, sulfate-, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol. Samples collected with Volumetric Absorptive Microsampling (VAMS).
Measured: Blood VAMS samples collected at day0 (D0): 1) before infusion(D0): predose , 2) 5 minutes after infusion (D0), 3) 5-120 minutes after infusion (D0): distribution phase, 4) 2 hours after infusion (D0), 5) 3-5 hours after infusion (D0): elimination phase
Cefazolin plasma and tissue concentrations
Plasma concentrations (mg/L) are stored in heparine blood tubes. Tissue concentrations (mg/L) are collected with a microdialysis device and stored in specific microdialysis vials.
Measured: At D0 sampled: Plasma: 1) predose, 2) 5 minutes after infusion, 3) 5-120 minutes, 4) 2 hours, 5) 3-5 hours; Microdialysis: 1) baseline (-30 - 0 minutes), 2) first 2 hours after dosing (every 30 minutes a sample), 3) next 3 hours (every 1 hour a sample)
Secondary outcomes (2)
Biomarkers values: enzymes
Determination of the presence and concentration of enzymes based on the values Aspartate aminotransferase (AST; U/L), Alanine aminotransferase (ALT; U/L), and Gamma-Glutamyl transpeptidase (GGT; U/L).
Measured: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
Biomarker values: proteins
Determination of the presence and concentration of proteins based on the values Bilirubin (total \& direct; g/L), serum creatinine (SCR; g/L), total protein (g/L), Albumin (g/L), and C-reactive protein (CRP; g/L).
Measured: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start22 Dec 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParacetamolStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anca Amza, Study director, Ghent University Hospital and Ghent Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585487
- Sponsor's protocol ID
- ONZ-2023-0432
- Acronym
- TISSUE
- Status last verified
- May 2026
- First submitted
- 13 Jan 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children
- ClinicalTrials.gov ID
- NCT07585487
- Acronym / sponsor ID
- TISSUE / ONZ-2023-0432
- Conditions
- Paracetamol, Cefazolin
- Keywords
- Paracetamol, Cefazolin, Overweight, children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacokinetic evaluations will be conducted to characterize the cefazolin plasma concentration-time profile, cefazolin penetration into subcutaneous adipose tissue, and paracetamol metabolization as assessed through blood sampling. The study population consists of children aged 2 to 15 years with either normal weight or overweight. All participants are admitted for a minor elective surgical procedure and will receive paracetamol and/or cefazolin as part of standard perioperative care.
During the procedure, multiple blood and tissue-fluid samples will be collected to quantify paracetamol and cefazolin concentrations in the bloodstream, as well as cefazolin concentrations in subcutaneous adipose tissue. The study aims to characterize drug concentration-time profiles in blood (paracetamol), plasma (cefazolin), and adipose tissue (cefazolin), and to compare these pharmacokinetic parameters between normal-weight and overweight children.
These data are essential to determine whether standard dosing regimens provide adequate drug exposure across different weight categories. Previous research indicates that achieving specific target concentrations in blood and tissue is necessary for optimal therapeutic effect, yet uncertainty remains regarding appropriate dosing in overweight children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Paracetamol or Cefazolin treatment in children with normal weight | – | Drug: Cefazolin, Drug: Paracetamol (drug) |
| Standard of Care Paracetamol or Cefazolin treatment in children with overweight | – | Drug: Cefazolin, Drug: Paracetamol (drug) |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing minor elective surgery at Ghent University Hospital
Key inclusion criteria (6 listed)
- Patient admitted to the operating room for minor elective surgery
- Patients undergoing general anesthesia for minor elective surgery
- Patient age: children from 2 years to 15 years
- Patients receiving cefazolin or paracetamol according to the standard procedure
- Intra-arterial (preferred) or intravenous access available for blood sampling
Key exclusion criteria (6 listed)
- Personal or family history of excessive bleeding
- Pre-existing coagulopathy and/or thrombocytopenia
- No catheter available for blood sampling
- Absence of parental consent
- Known allergy to one of the components of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinAlso: CephazolinProphylactic Cefazolin treatment per standard-of-care | Drug | Standard of Care Paracetamol or Cefazolin treatment in children with normal weight, Standard of Care Paracetamol or Cefazolin treatment in children with overweight |
| Paracetamol (drug)Also: AcetaminophenPreoperative dose of paracetamol, as per standard-of-care | Drug | Standard of Care Paracetamol or Cefazolin treatment in children with normal weight, Standard of Care Paracetamol or Cefazolin treatment in children with overweight |
Primary outcome
Blood concentrations of paracetamol and its metabolites
Time frame: Blood VAMS samples collected at day0 (D0): 1) before infusion(D0): predose , 2) 5 minutes after infusion (D0), 3) 5-120 minutes after infusion (D0): distribution phase, 4) 2 hours after infusion (D0), 5) 3-5 hours after infusion (D0): elimination phase
Blood concentrations (mg/L) of paracetamol and its metabolites: glucuronide-, sulfate-, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol. Samples collected with Volumetric Absorptive Microsampling (VAMS).
Cefazolin plasma and tissue concentrations
Time frame: At D0 sampled: Plasma: 1) predose, 2) 5 minutes after infusion, 3) 5-120 minutes, 4) 2 hours, 5) 3-5 hours; Microdialysis: 1) baseline (-30 - 0 minutes), 2) first 2 hours after dosing (every 30 minutes a sample), 3) next 3 hours (every 1 hour a sample)
Plasma concentrations (mg/L) are stored in heparine blood tubes. Tissue concentrations (mg/L) are collected with a microdialysis device and stored in specific microdialysis vials.
2 secondary outcomes
Biomarkers values: enzymes
Time frame: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
Biomarker values: proteins
Time frame: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anca Amza study director
Ghent University Hospital and Ghent Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paracetamol and Cefazolin, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pieter De Cock, Prof. Apr (+32 9 332 29 69, pieter.decock@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentrations of paracetamol and its metabolites (time frame: Blood VAMS samples collected at day0 (D0): 1) before infusion(D0): predose , 2) 5 minutes after infusion (D0), 3) 5-120 minutes after infusion (D0): distribution phase, 4) 2 hours after infusion (D0), 5) 3-5 hours after infusion (D0): elimination phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.