Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial.

Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial. - Pain treatment of newborns:paracetamol rectal versus iv administration

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35587

Enrollment

Registered

2010-10-14

Start date

2011-03-31

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

pijn pain suffer

Interventions

Intravenous prescription dose: The dose is dependent on the gestational age. Preterm neonates with a gestational age of 26 -32 weeks: Loading dose 20 mg/kg, thereafter intermittent dosage of 10 mg/kg

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. gestational age > 26 weeks 2. weight at birth for gestational age /

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. no necessity for pain treatment 2. macrosomia (weight at birth > p 97) 3. (severe) congenital abnormalities 4. less than 48 hours pain treatment is required 5. neonates are sedated or paralysed (Comfortneoscore impossible) 6. severe asphyxia (Apgar score

Design outcomes

Primary

Measure	Time frame
Paracetamol administered rectally versus intraveneously in neonates Pharmacokinetics Optimal therapeutic dose Toxicity (renal and hepatic)	—

Secondary

Measure	Time frame
Paracetamol as administered rectally versus intraveneously in neonates Pharmacodynamics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)