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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
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Elisabeth Norman, Lund University

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Fentanyl (5 microgram/ml) prediluted ampoules Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).





Primary Outcome Measures :
  1. Pharmacokinetics; fentanyl clearance [ Time Frame: 48 hours ]
    Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.

  2. Pharmacokinetics; fentanyl clearance [ Time Frame: 6 hours ]
    The serum concentration values will be analysed as Area under the curve, AUC

  3. Pharmacodynamics; Amplitude integrated electroencephalography (aEEG) [ Time Frame: 6 hours ]
    Background activity

  4. Pharmacodynamics; Amplitude integrated electroencephalography (aEEG), [ Time Frame: 6 hours ]
    Seizure activity


Secondary Outcome Measures :
  1. Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]
    Change in heart rate

  2. Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]
    Change in mean arterial blood pressure

  3. Pharmacodynamics, change in vital parameters [ Time Frame: 6 hours ]
    Change in near infrared spectroscopy

  4. 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)

  5. Pharmacodynamics, hormonal response [ Time Frame: 48 hours ]
    Blood levels of cortisol



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Sweden
Neonatal Intensive Care Unit, Skåne University Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Lund University
Karolinska Institutet
Investigators
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Principal Investigator: Vineta Fellman, Professor Dep. of Pediatrics, Lund University, Sweden

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Responsible Party: Elisabeth Norman, MD, PhD, Senior Consultant, Lund University
ClinicalTrials.gov Identifier: NCT03897452     History of Changes
Other Study ID Numbers: EU-Grant 223767
2011-000310-19 ( EudraCT Number )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Keywords provided by Elisabeth Norman, Lund University:
analgesia
neonates
procedural pain
pain assessment
physiological response
pharmacogenetics
Additional relevant MeSH terms:
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Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics