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

NCT ID: NCT03897452

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-12-31

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fentanyl for procedural pain

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.

Group Type: EXPERIMENTAL

Fentanyl (5 microgram/ml) prediluted ampoules

Intervention Type: DRUG

Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure.

Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation).

Interventions

Fentanyl (5 microgram/ml) prediluted ampoules

Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure.

Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Norman

MD, PhD, Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vineta Fellman, Professor

Role: PRINCIPAL_INVESTIGATOR

Dep. of Pediatrics, Lund University, Sweden

Locations

Neonatal Intensive Care Unit, Skåne University Hospital

Lund, , Sweden

Countries

Sweden

Other Identifiers

2011-000310-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EU-Grant 223767

Identifier Type: -

Identifier Source: org_study_id