Optimizing Pain Treatment in Pre-Term Neonates

Optimizing Pain Treatment in Pre-Term Neonates - Morphine study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38405

Enrollment

Registered

2011-12-29

Start date

2012-04-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

prematuur geboren kinderen criticall illness prematurity pain

Interventions

Morphine: 0.05 mg/kg loading dose of morphine will be given by an intravenous infusion over 30-minutes in preterm neonates with a GA of less than 29 weeks, followed by a continuous infusion of 0.00

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Preterm neonates of both genders and all races between 23 and 32 weeks postnatal age less than 30 days an indwelling (peripheral or umbilical) arterial line, and a clinical indication for intravenous morphine administration

Exclusion criteria

Exclusion criteria: Neonates with severe asphyxia, grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations, neurological disorders, and those receiving continuous or intermittent neuromuscular blockers. clinical or biochemical evidence of hepatic and renal compromise (including systemic hypoperfusion) or received drugs that are UGT2B7 substrates (including Lorazepam, ibuprofen, valproic acid, naloxone and other morphine derivatives or propanolol)

Design outcomes

Primary

Measure	Time frame
Safety: Infants will have continuous monitoring of vital signs, oxygen saturation, movements and adverse events to determine the safety of morphine. Pharmacodynamics: The Neonatal Infant Pain (NIP) and Premature Infant Pain Profile (PIPP) will be performed at baseline, (prior to drug administration)and at pre-determined time intervals after the dose to assess pain for the efficacy of morphine. Pharmacokinetics: The concentrations of morphine and its metabolites will be measured in plasma and urine at pre-determined time points and will be used to calculate the formation and elimination clearances of morphine and its metabolites. Pharmacogenetics: Impact of genetic variation in the UGT2B7 gene on the formation clearances of the morphine metabolites will be studied as well as the genetic variation in the µ-opioid receptor, COMT, and β-arrestin 2 genes on the PD of morphine use.	—

Measure

Time frame

Safety: Infants will have continuous monitoring of vital signs, oxygen saturation, movements and adverse events to determine the safety of morphine. Pharmacodynamics: The Neonatal Infant Pain (NIP) and Premature Infant Pain Profile (PIPP) will be performed at baseline, (prior to drug administration)and at pre-determined time intervals after the dose to assess pain for the efficacy of morphine. Pharmacokinetics: The concentrations of morphine and its metabolites will be measured in plasma and urine at pre-determined time points and will be used to calculate the formation and elimination clearances of morphine and its metabolites. Pharmacogenetics: Impact of genetic variation in the UGT2B7 gene on the formation clearances of the morphine metabolites will be studied as well as the genetic variation in the µ-opioid receptor, COMT, and β-arrestin 2 genes on the PD of morphine use.

—

Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)