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

Lund University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Fentanyl (5 microgram/ml) prediluted ampoules

Study type: Interventional

Funder types: Other

Identifiers

NCT03897452

EU-Grant 223767

2011-000310-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Fentanyl for procedural pain

Experimental group

Description:

A dose of Fentanyl 5 microgram/ml, 0.5 microgram/kg (anticipated medium pain) or 2 microgram/kg (anticipated strong pain) will be given prior to a painful procedure during NICU-care. Repeated doses or complementary analgesics will be administered according to pain assessment and clinical judgement. This is not an RCT with several arms.

Treatment:

Drug: Fentanyl (5 microgram/ml) prediluted ampoules