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

L

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;

  • 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

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)

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems