NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study

• Status: Completed
• Trial end date: 2014-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University
• Collaborator: Karolinska Institutet
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Clinical indication for analgesia before any of following procedures;

1. insertion of peripheral IV-catheter

2. insertion of arterial cannula

3. insertion of chest tube

4. other skin breaking procedure.

• Possibility to obtain blood samle after the procedure (indwelling line)

• Infants all gestational ages.

• Postnatal age 0-28 days

• Informed written parental concent

Exclusion Criteria:

• Concurrent or previous opioid administration (72 h interval required)

• Abdominal surgery

• Major chromosomal anomaly

• Neonatal encephalopathy

• Use of muscle relaxant

• Hypothermia treatment after hypoxic-ischemic insult

• Clinical or biochemical evidence of hepatic failure

• Participation in other intervention trial