Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-24

Study Completion Date

2021-04-01

Brief Summary

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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.

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Detailed Description

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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

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Asphyxia Neonatorum

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Fentanyl

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

Fentanyl

Intervention Type DRUG

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.

Fentanyl and Clonidine

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

Fentanyl and clonidine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No