NCT03177980

Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants

Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants - a Prospective Pharmacokinetic/Pharmacodynamic/Pharmacogenetic Observational Study. Cohort 1 in The SANNI Project.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 36 Weeks
• Healthy volunteers: Not accepted

Summary

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in the NICU.

Detailed description

All patients that are admitted to the study neonatal intensive care units (NICUs) for hypothermic treatment due to perinatal asphyxia are potential study patients, and their parents will be asked for consent. The patient will be treated according to clinical guidelines and will be included in the study if in need for fentanyl and clonidine according to clinical judgment (HIE and pain scores) and as decided by the responsible clinical doctor. The dosing and administration of the drugs will be implemented according to an algorithm based on pain scoring results. Apart from extra blood sampling, the bedside monitoring, investigations (electroencephalography (EEG), echocardiography (ECG), ultrasound of the brain and magnetic resonance imaging, (MRI)) and follow-up (neurologic examination) are the same as for all infants receiving hypothermia according to national and international guidelines. A brief standardised pain stimulation will be performed as part of the pain and stress assessment. In total 50 infants will be included.

Conditions

• Asphyxia Neonatorum

Interventions

Type	Name	Description
DRUG	Fentanyl	The dosing and administration of fentanyl will serve as the first drug intervention in infants in need of analgesia according to an algorithm based on pain scoring results.
DRUG	Fentanyl and clonidine	In infants in need of further analgesia clonidine will be administered as an add on drug according to an algorithm based on pain scoring results.

Timeline

• Start date: 2017-04-24
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2017-06-06
• Last updated: 2021-06-09

Locations

2 sites across 1 country: Sweden