Safety of paracetamol in neonates

Intravenous and oral paracetamol in neonates: safety and ethanol-drug interactions – the PARASHUTE Trial - PARASHUTE trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002724-25-DK

Enrollment

120

Registered

2017-07-07

Start date

2017-11-16

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver toxicity following prolonged administration of i.v. or oral paracetamol MedDRA version: 20.1 Level: LLT Classification code 10019850 Term: Hepatotoxic effect System Organ Class: 100000004871

Interventions

Trade Name: Paracetamol B. Braun Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paracetamol CAS Number: 103-90-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Neonates any gestational age and weight of both genders • Post menstrual age up to 44 full weeks at inclusion • Intended treatment with i.v. paracetamol for any indication or intended treatment with p.o. paracetamol for one of the following indications: fractures, cranial haemorrhages, chest tubes, postoperative pain or painfull skin lessions. • Informed written consent from both parents or legal guardian, Informed Consents must be approved by the Danish Ethical Committee • Signing consent form can be postponed 24 hours after treatment start Are the trial subjects under 18? yes Number of subjects for this age range: 120 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: • The responsible clinicians finds the patient unsuitable for trial • Hypersensitivity towards paracetamol

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore if long term (> 72 hours) use of intravenous or oral paracetamol administered to neonates leads to risk of hepatotoxicity assessed by safety biomarkers, paracetamol metabolites (maturation pharmacokinetics) and accumulation of paracetamol. ; Secondary Objective: • To explore If ethanol containing drugs (phenobarbital) causes a measurable rise in p-ethanol and if the presence of ethanol change the pharmacokinetics of paracetamol in neonates • COMFORTneo pain scores ; Primary end point(s): Concentration-time data on plasma paracetamol, paracetamol-sulphate, paracetamol-glucuronide, oxidative metabolites and liver biomarkers (ALAT, PP, bilirubin) in neonates before, during and after multiple administrations of i.v. paracetamol with focus on long-term (>72 hours) treatment. Patients serve as their own control. ; Timepoint(s) of evaluation of this end point: The primary end points are evaluated at baseline, in steady state, when opportunistic blood sampling occurs and after end of treatment.	—

Measure

Time frame

Main Objective: To explore if long term (> 72 hours) use of intravenous or oral paracetamol administered to neonates leads to risk of hepatotoxicity assessed by safety biomarkers, paracetamol metabolites (maturation pharmacokinetics) and accumulation of paracetamol. ; Secondary Objective: • To explore If ethanol containing drugs (phenobarbital) causes a measurable rise in p-ethanol and if the presence of ethanol change the pharmacokinetics of paracetamol in neonates • COMFORTneo pain scores ; Primary end point(s): Concentration-time data on plasma paracetamol, paracetamol-sulphate, paracetamol-glucuronide, oxidative metabolites and liver biomarkers (ALAT, PP, bilirubin) in neonates before, during and after multiple administrations of i.v. paracetamol with focus on long-term (>72 hours) treatment. Patients serve as their own control. ; Timepoint(s) of evaluation of this end point: The primary end points are evaluated at baseline, in steady state, when opportunistic blood sampling occurs and after end of treatment.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: P-ethanol will only be measured if the patient has received phenobarbital within 24 hours of blood-sampling. metabolites are measured as outlined in primary end points. COMFORT-neo pain scores is evaluated when p-paracetamol is measured in addition to clinical scores. ; Secondary end point(s): Levels of paracetamol metabolites and levels of p-ethanol in patients receiving one or more ethanol containing drugs compared to the patients not receiving ethanol containing drugs. COMFORT-neo pain scores.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: P-ethanol will only be measured if the patient has received phenobarbital within 24 hours of blood-sampling. metabolites are measured as outlined in primary end points. COMFORT-neo pain scores is evaluated when p-paracetamol is measured in addition to clinical scores. ; Secondary end point(s): Levels of paracetamol metabolites and levels of p-ethanol in patients receiving one or more ethanol containing drugs compared to the patients not receiving ethanol containing drugs. COMFORT-neo pain scores.

—

Countries

Denmark

Contacts

Public ContactSissel Haslund-Krog

Bispebjerg University Hospital

sissel.sundell.haslund-krog.01@regionh.dk004538635806

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026