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

NCT03897452 | Completed Phase 4 DMC

• 2 other identifiers: EU-Grant 2237672011-000310-19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

analgesia; neonates; procedural pain; pain assessment; physiological response; pharmacogenetics

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics; fentanyl clearance

  Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.

  48 hours

• Pharmacokinetics; fentanyl clearance

  The serum concentration values will be analysed as Area under the curve, AUC

  6 hours

• Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)

  Background activity

  6 hours

• Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),

  Seizure activity

  6 hours

Secondary Outcomes (5)

• Pharmacodynamics, change in vital parameters

  6 hours

• Pharmacodynamics, change in vital parameters

  6 hours

• Pharmacodynamics, change in vital parameters

  6 hours

• Pharmacodynamics, behavioural response

  6 hours

• Pharmacodynamics, hormonal response

  48 hours

Study Arms (1)

Fentanyl for procedural pain

EXPERIMENTAL

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.

Drug: Fentanyl (5 microgram/ml) prediluted ampoules

Interventions

Fentanyl (5 microgram/ml) prediluted ampoules 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).

Fentanyl for procedural pain

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical indication for analgesia before any of following procedures;
• insertion of peripheral IV-catheter
• insertion of arterial cannula
• insertion of chest tube
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Neonatal Intensive Care Unit, Skåne University Hospital

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Pain; Agnosia; Pain, Procedural

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vineta Fellman, Professor

  Dep. of Pediatrics, Lund University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Consultant

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: April 1, 2019
• Study Start: November 1, 2012
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

SE (1)