Health TrialsbyHealthPanel

Anesthetics and Analgesics in Children

ConditionsAnesthesiaPain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-17
SponsorChi Dang Hornik

About this trial

The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

0 to <18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range)

Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)

Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)

Receiving one or more drugs of interest (DOI) per local standard of care

Disqualifiers

Known pregnancy

Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)

Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Trial population

Approximately 60 participants will be enrolled to each of the study drug of interests (DOI) cohorts. Participants who satisfy eligibility criteria and are receiving one or more DOIs per standard of care will be consented into the study and assigned to the corresponding DOI cohort. DOI cohort assignments will be at the discretion of the treating physician based on the DOIs that are administered per standard of care. Participants will be selected from a variety of centers including but not limited to trauma and intensive care units. Participants will not be randomized. Participants may count towards 1 or more DOIs within the same 90-day period.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Ketorolac Tromethamine

    Drug

    IV ketorolac will be given per standard of care, not prescribed for this study

  • Hydromorphone

    Drug

    IV Hydromorphone will be given per standard of care, not prescribed for this study

  • Ketamine

    Drug

    IV Ketamine will be given per standard of care, not prescribed for this study

  • Oxycodone

    Drug

    PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study

  • Morphine

    Drug

    IV Morphine will be given per standard of care, not prescribed for this study

Treatment groups

551 Participants
are divided into 1 treatment group
Group A: Drug of Interest5 interventions

Trial outcomes

Primary outcomes

1

Clearance (CL) or apparent oral clearance (CL/F)

Time frame
up to 48 hours post dose
2

Volume of distribution (V) or apparent oral volume of distribution (V/F)

Time frame
up to 48 hours post dose
3

Elimination rate constant (ke)

Time frame
up to 48 hrs post dose
4

Half-life (t1/2)

Time frame
up to 48 hrs post dose

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chi Dang Hornik

Lead sponsor

Duke University

Sponsor institution

The Emmes Company, LLC

Collaborator

Source ClinicalTrials.gov
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