NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study
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|ClinicalTrials.gov Identifier: NCT03897452|
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Fentanyl (5 microgram/ml) prediluted ampoules||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 31, 2014|
|Actual Study Completion Date :||December 31, 2014|
Experimental: 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.
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).
- Pharmacokinetics; fentanyl clearance [ Time Frame: 48 hours ]Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.
- Pharmacokinetics; fentanyl clearance [ Time Frame: 6 hours ]The serum concentration values will be analysed as Area under the curve, AUC
- Pharmacodynamics; Amplitude integrated electroencephalography (aEEG) [ Time Frame: 6 hours ]Background activity
- Pharmacodynamics; Amplitude integrated electroencephalography (aEEG), [ Time Frame: 6 hours ]Seizure activity
- Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]Change in heart rate
- Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]Change in mean arterial blood pressure
- Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]Change in near infrared spectroscopy
- Pharmacodynamics, behavioural response [ Time Frame: 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 [ Time Frame: 48 hours ]Blood levels of cortisol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897452
|Neonatal Intensive Care Unit, Skåne University Hospital|
|Lund, Sweden, 221 85|
|Principal Investigator:||Vineta Fellman, Professor||Dep. of Pediatrics, Lund University, Sweden|