RecruitingNot Applicable

Anesthetics and Analgesics in Children

United States500 participantsStarted 2018-12-13

Plain-language summary

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

Who can participate

Age range0 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Meeting DOI-specific inclusion criteria (See Appendices)

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: up to 48 hours post dose

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

Timeframe: up to 48 hours post dose

Elimination rate constant (ke)

Timeframe: up to 48 hrs post dose

Half-life (t1/2)

Timeframe: up to 48 hrs post dose

Absorption rate constant (ka)

Timeframe: up to 48 hrs post dose

Area under the curve (AUC)

Timeframe: up to 48 hrs post dose

Maximum concentration (CMAX)

Timeframe: up to 48 hrs post dose

Time to achieve maximum concentration (TMAX)

Timeframe: up to 48 hrs post dose

Trial details

NCT IDNCT03427736

SponsorChi Dang Hornik

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-30

Contact for this trial

Kady-Ann Steen-Burrell, PhD

919-530-9711 kady.ann.steen.burrell@duke.edu

View on ClinicalTrials.gov More Anesthesia trials

Who can participate

Age range0 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Meeting DOI-specific inclusion criteria (See Appendices)

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: up to 48 hours post dose

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

Timeframe: up to 48 hours post dose

Elimination rate constant (ke)

Timeframe: up to 48 hrs post dose

Half-life (t1/2)

Timeframe: up to 48 hrs post dose

Absorption rate constant (ka)

Timeframe: up to 48 hrs post dose

Area under the curve (AUC)

Timeframe: up to 48 hrs post dose

Maximum concentration (CMAX)

Timeframe: up to 48 hrs post dose

Time to achieve maximum concentration (TMAX)

Timeframe: up to 48 hrs post dose