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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Fentanyl (5 microgram/ml) prediluted ampoules

• Registration Number: NCT03897452
• Lead Sponsor: Lund University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Study First Submitted: 2019-02-13
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Study First Posted: 2019-04-01
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fentanyl for procedural pain	Fentanyl (5 microgram/ml) prediluted ampoules	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics; fentanyl clearance	6 hours	The serum concentration values will be analysed as Area under the curve, AUC
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)	6 hours	Background activity
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),	6 hours	Seizure activity

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics, behavioural response	6 hours	Pain assessment with the Premature Infant Pain Profile-revised (PIPP) score for procedural pain (0-21, with the highest value if strong pain in extremely preterm infants)
Pharmacodynamics, hormonal response	48 hours	Blood levels of cortisol
Pharmacodynamics, change in vital parameters	6 hours	Change in near infrared spectroscopy

Trial Locations

Locations (1)

Neonatal Intensive Care Unit, Skåne University Hospital; 🇸🇪 Lund, Sweden