Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants (SANNI 1)

Region Skane

Status: Completed

Conditions: Asphyxia Neonatorum

Treatments: Drug: Fentanyl; Drug: Fentanyl and clonidine

Study type: Observational

Funder types: Other

Identifiers

NCT03177980

2015-002470-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 36+ weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Term infants (≥ gw 36+0) who, according to national guidelines (6), will receive hypothermic treatment following perinatal asphyxia, and are in need for analgesic or sedative medication according to clinical judgment based on Thomsons score and ALPS-Neo.
• Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling
• Informed and written parental consent.

Exclusion criteria

• Atrioventricular (AV)- block I-III or heart rate < 70 .
• Serious coronary heart disease with need for postnatal surgery
• Mean arterial blood pressure <35 mmHg despite adequate treatment.

Trial design

49 participants in 2 patient groups

Fentanyl

Description:

All infants in need of analgesia according to an algorithm based on pain assessment results will receive fentanyl as the first analgesic drug.

Treatment:

Drug: Fentanyl

Fentanyl and Clonidine

Description:

Infants in need of further analgesia according to an algorithm based on pain assessment results will receive fentanyl and clonidine as the analgesic drugs.

Treatment:

Drug: Fentanyl and clonidine