Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

Region Skane

Status: Withdrawn

Conditions: Intensive Care, Neonatal; Analgesia; Hypnotics and Sedatives

Treatments: Drug: dexmedetomidine

Study type: Observational

Funder types: Other

Identifiers

NCT06482775

2015-002506-37

Details and patient eligibility

About

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Phase III - therapeutic confirmatory study.

Full description

The patients will be treated according to clinical guidelines and judgement as decided by the responsible clinical doctor.

The dosing and administration of dexmedetomidine will be implemented according to an algorithm based on pain scoring results.

Apart from extra blood sampling and extended bedside monitoring for amplitude-integrated EEG (aEEG), Near InfraRed Spectroscopy (NIRS), and Galvanic Skin Response (GSR) the care is according to clinical routine.

In total 100 infants will be included.

Sex: All

Ages: Under 27 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborn infants: - born 34+0 gw with a need for dexmedetomidine for analgesic and/or sedative treatment after postnatal surgical correction of congenital malformations and who will be cared for in the PICU (postoperative intensive care unit) and in a some few cases in the NICU (neonatal intensive care unit), or
• with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment and cared for in the NICU.
• Existing arterial or venous cannulas/catheters for repeated nontraumatic blood sampling
• Informed and written parental consent obtained before study start.

Exclusion criteria

• Infant older than age corresponding to gw 46+0
• Previous treatment with the dexmedetomidine within 72 hours (only for postoperative infants).
• Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia.
• Ongoing renal replacement treatment
• Any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.

Trial design

0 participants in 1 patient group

dexmedetomidine

Description:

Infusion of dexmedetomidine 4 microgram/mL.

Treatment:

Drug: dexmedetomidine