Recruiting

Anesthetics & Analgesics

Sponsor:

Chi Dang Hornik

Code:

NCT03427736

Conditions

Anesthesia

Pain

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Ketorolac Tromethamine

Hydromorphone

Ketamine

Oxycodone

Morphine

Study Details

Brief summary:

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

Conditions

Anesthesia

Pain

Study ID

NCT03427736

Start date

Dec 13, 2018

Status verified date

Aug, 2026

Completion date

Sep 9, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

551 participants

Anticipated

Interventions and Outcome Measures

Arms

Drug of Interest

Individuals receiving anesthetics or analgesics per standard of care

Interventions

Ketorolac Tromethamine

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

Hydromorphone

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

Ketamine

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

Oxycodone

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

Morphine

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

Primary outcome measure

  • Clearance (CL) or apparent oral clearance (CL/F) [ Time Frame: up to 48 hours post dose ]
  • Volume of distribution (V) or apparent oral volume of distribution (V/F) [ Time Frame: up to 48 hours post dose ]
  • Elimination rate constant (ke) [ Time Frame: up to 48 hrs post dose ]
  • Half-life (t1/2) [ Time Frame: up to 48 hrs post dose ]
  • Absorption rate constant (ka) [ Time Frame: up to 48 hrs post dose ]
  • Area under the curve (AUC) [ Time Frame: up to 48 hrs post dose ]
  • Maximum concentration (CMAX) [ Time Frame: up to 48 hrs post dose ]
  • Time to achieve maximum concentration (TMAX) [ Time Frame: up to 48 hrs post dose ]

Central Contacts and Locations

Central contacts

Locations

Lucile Packard Children's Hospital

Recruiting

Stanford, California, United States, 94305

Contacts

Radhamangalam Ramamurthi

rjram@stanford.edu

Jyoti Bhamidipati

jyotib@stanford.edu

Ann and Robert H. Lurie Childrens Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27701

Contacts

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

More Information

Sponsor

Chi Dang Hornik

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chi Dang Hornik on 2026-08-05.