Optimizing Pain Treatment in Pre-Term Neonates

• Conditions: Critically Ill Premature Neonates between 23 and 32 weeks of gestation who are receiving morphine as part of their routine medical management of pain or other medically indicated condition for which the drug is prescribed.; MedDRA version: 14.1Level: PTClassification code 10056350Term: Pain managementSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-001783-21-NL
• Lead Sponsor: Childrens's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified