What this study is
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
What's being tested
- Ketorolac Tromethamine
Intervention · DRUG
IV ketorolac will be given per standard of care, not prescribed for this study
- Hydromorphone
Intervention · DRUG
IV Hydromorphone will be given per standard of care, not prescribed for this study
- Ketamine
Intervention · DRUG
IV Ketamine will be given per standard of care, not prescribed for this study
- Oxycodone
Intervention · DRUG
PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study
- Morphine
Intervention · DRUG
IV Morphine will be given per standard of care, not prescribed for this study
- Fentanyl (IV)
Intervention · DRUG
Fentanyl IV will be administered intravenously or intramuscularly per standard of care, not prescribed for this study
Study details
- Official title
- Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
- Sponsor
- Chi Dang Hornik
- Conditions
- Anesthesia · Pain
- Enrolling
- 551 people
- Starts
- 2018-12-13
- Est. completion
- 2027-09-09
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Months – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 6 months 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (13)
7 openLucile Packard Children's Hospital
Stanford, California, United States
- Radhamangalam Ramamurthi · Contactrjram@stanford.edu
- Jyoti Bhamidipati · Contactjyotib@stanford.edu
RecruitingAlfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
- Marisa Meyer, DO · Contact1-302-651-4021marisa.meyer@nemours.org
- Gwen Pellicciotti, RN, BSN · Contact1-484-824-4902gwen.pellicciotti@nemours.org
RecruitingAnn and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
- Amy Fang, MD · Contact1-312-227-4448zafang@luriechildrens.org
- Richa Mehta · Contact1-312-227-4448rmehta@luriechildrens.org
RecruitingDuke University Medical Center
Durham, North Carolina, United States
- Melissa Harward · Contact(919) 668-3910Melissa.Harward@duke.edu
- Chi Hornik · Contact919.970.6680chi.dang@duke.edu
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
- John Costello, MD · Contact843-792-9570costello@musc.edu
- Mary Freeman · Contact843-792-5762freemanme@musc.edu
RecruitingChildren's Hospital Colorado
Aurora, Colorado, United States
TerminatedCardinal Glennon Children's Hospital
St Louis, Missouri, United States
Active, not recruitingWashington University School of Medicine
St Louis, Missouri, United States
TerminatedOregon Health and Science University
Portland, Oregon, United States
Active, not recruitingDell Children's Medical Center of Texas
Austin, Texas, United States
WithdrawnBaylor College of Medicine
Houston, Texas, United States
Withdrawn
2 sites outside the US
The Hospital for Sick Children
Toronto, Ontario, Canada
- Yaron Finkelstein · Contact1-416-813-5317yaron.finkelstein@sickkids.ca
- Maggie Rumantir · Contact1-416-813-7654maggie.rumantir@sickkids.ca
RecruitingHospital Sainte-Justine
Montreal, Quebec, Canada
- Julie Autmizguine · Contact1-514-345-4931julie.autmizguine@umontreal.ca
- Clotilde Gravel · Contact1-514-345-4931clotilde.gravel.hsj@ssss.gouv.qc.ca
Recruiting
Study team
Sponsor
Chi Dang Hornik
Study ID Pro00088893
Principal investigator
Chi Hornik, PharmD
Duke Clinical Research Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.