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Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants

NCT03177980 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2021-06-09

No results posted yet for this study

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.

Conditions

  • Asphyxia Neonatorum

Interventions

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.

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • Örebro University, Sweden

    collaborator OTHER

  • The Swedish Research Council

    collaborator OTHER_GOV

  • University of Colorado, Denver

    collaborator OTHER

  • University of Tartu

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Elisabeth Norman, MD · Region Skane and Lunds University

Eligibility

Min Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03177980 on ClinicalTrials.gov