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

Pain Clinical Trial

Official title:

NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study. Prestudy to NeoOpioid; No Pain During Infancy by Adapting Off-patent Medicines. EU FP7:HEALTH - 2007-4.2-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897452
• Other study ID #: EU-Grant 223767
• Secondary ID: 2011-000310-19
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: December 31, 2014

Study information

• Verified date: March 2019
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Sweden	Neonatal Intensive Care Unit, Skåne University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics; fentanyl clearance	Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.	48 hours
Primary	Pharmacokinetics; fentanyl clearance	The serum concentration values will be analysed as Area under the curve, AUC	6 hours
Primary	Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)	Background activity	6 hours
Primary	Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),	Seizure activity	6 hours
Secondary	Pharmacodynamics, change in vital parameters	Change in heart rate	6 hours
Secondary	Pharmacodynamics, change in vital parameters	Change in mean arterial blood pressure	6 hours
Secondary	Pharmacodynamics, change in vital parameters	Change in near infrared spectroscopy	6 hours
Secondary	Pharmacodynamics, behavioural response	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)	6 hours
Secondary	Pharmacodynamics, hormonal response	Blood levels of cortisol	48 hours