Clinical trial

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

Name

Pro00088893

Description

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

Trial arms

Trial start

2018-12-13

Estimated PCD

2025-06-30

Trial end

2025-06-30

Status

Recruiting

Treatment

Ketorolac Tromethamine

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

Arms:

Drug of Interest

Other names:

Toradol

Hydromorphone

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

Arms:

Drug of Interest

Other names:

Hydromorphone hydrochloride, Dilaudid

Ketamine

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

Arms:

Drug of Interest

Other names:

Ketamine Hydrochloride

Oxycodone

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

Arms:

Drug of Interest

Other names:

Oxycodone Hydrochloride

Morphine

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

Arms:

Drug of Interest

Other names:

Morphine Sulfate

Size

460

Primary endpoint

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

up to 48 hours post dose

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

up to 48 hours post dose

Elimination rate constant (ke)

up to 48 hrs post dose

Half-life (t1/2)

up to 48 hrs post dose

Absorption rate constant (ka)

up to 48 hrs post dose

Area under the curve (AUC)

up to 48 hrs post dose

Maximum concentration (CMAX)

up to 48 hrs post dose

Time to achieve maximum concentration (TMAX)

up to 48 hrs post dose

Eligibility criteria

Inclusion Criteria: 1. 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) 2. Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable) 3. Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB) 4. Receiving one or more drugs of interest (DOI) per local standard of care 5. Meeting DOI-specific inclusion criteria (See Appendices) Exclusion Criteria: 1. Known pregnancy 2. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) 3. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Left over specimens will be de-identified and sent to the NICHD biorepository at the end of the study. These specimens may be made available to other researchers. Future unspecified tests conducted may include genetic testing.'}, 'enrollmentInfo': {'count': 460, 'type': 'ESTIMATED'}}

Updated at

2024-01-18

1 organization

4 products

1 drug

2 indications

Organization

Kanecia Obie Zimmerman

Product

Ketorolac Tromethamine

Indication

Anesthesia