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Anesthetics and Analgesics in Children (ANA01)

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ClinicalTrials.gov Identifier: NCT03427736
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
The EMMES Corporation
Information provided by (Responsible Party):
Christoph P Hornik, MD MPH, Duke University

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

Condition or disease Intervention/treatment
Anesthesia Pain Drug: Ketamine Drug: Hydromorphone

Detailed Description:
This is a research study to find out what the side effects are of certain drugs that are commonly used for pain (hydromorphone) and to put people to sleep for surgery (ketamine). The researchers also want to know how the drug is broken down in the body. Participants will be given these drugs as they are prescribed by their regular doctor. As part of the participant's standard of care, doctors will perform tests, ask questions, review medical information and measure vital signs (heart rate, blood pressure, etc). The researchers will collect information that doctors have already written in the medical records. The research study team will collect blood from participants at certain time points depending on when the participant was first given the drug (up to 5 samples over the course of 10 to 48 hours). Parents will complete questionnaires about the study participant. Parents will continue to complete those same questionnaires for up to 12 months after the participant was first given the drug.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Drug of Interest
Individuals receiving ketamine (IV) or hydromorphone (IV) per standard of care
Drug: Ketamine
IV Ketamine will be given per standard of care, not prescribed for this study
Other Name: Ketalar

Drug: Hydromorphone
IV Hydromorphone will be given per standard of care, not prescribed for this study
Other Names:
  • Hydromorphone hydrochloride
  • Dilaudid




Primary Outcome Measures :
  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 ]
  5. Absorption rate constant (ka) [ Time Frame: up to 48 hrs post dose ]
  6. Area under the curve (AUC) [ Time Frame: up to 48 hrs post dose ]
  7. Maximum concentration (CMAX) [ Time Frame: up to 48 hrs post dose ]
  8. Time to achieve maximum concentration (TMAX) [ Time Frame: up to 48 hrs post dose ]

Biospecimen Retention:   Samples With DNA
Left over specimens may be sent to the NICHD biorepository at the consent of the study participant. This is optional. But future unspecified tests conducted may include genetic testing.


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

Inclusion Criteria:

  • 2 years to < 18 years at the time of enrollment
  • Parent is able to understand the consent process and provides informed consent/HIPAA
  • Participant provides assent and as required by the institutional review board
  • Receiving one or more drugs of interest (DOI) per local standard of care meeting DOI-specific inclusion criteria

Exclusion Criteria:

  • Known pregnancy
  • Extracorporeal life support (i.e., Extracorporeal membrane oxygenation, dialysis, ventricular assist device)
  • Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427736


Contacts
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Contact: Cheryl Alderman 919-668-8349 cheryl.alderman@duke.edu
Contact: Gary Furda 919-668-7253 gary.furda@duke.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Scott Schulman, MD    415-502-4222    scott.schulman@ucsf.edu   
Contact: Anne Mckenzie    1-415-476-3758    anne.mckenzie@ucsf.edu   
Lucile Packard Children's Hospital Recruiting
Stanford, California, United States, 94305
Contact: Alexandria George    650-232-9152    josepha3@stanford.edu   
Contact: Yan He    1-650-724-2320    yh52@stanford.edu   
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Peter Mourani, MD    303-724-2390    peter.mourani@childrenscolorado.org   
Contact: Alle Rutebemberwa    1-720-777-5380    alle.rutebemberwa@childrenscolorado.org   
United States, Delaware
Alfred I. DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Marisa Meyer, MD    302-651-4021    marisa.meyer@nemours.org   
Contact: Ramany John    1-302-298-7521    ramany.john@nemours.org   
United States, Missouri
Cardinal Glennon Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Marian Malone    314-577-5395    marian.malone@health.slu.edu   
Contact: Erik Madsen, MD    314-577-1590    madsenec@slu.edu   
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mike Montana, MD, PhD    314-565-8119    montana@wustl.edu   
Contact: Dani Tallchief, RN    314-747-1663    dtallchief@wustl.edu   
United States, New Mexico
University of New Mexico, Health Sciences Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Olivia Nunez    505-272-9898    odnunez@salud.unm.edu   
Contact: Sarah Sanders    1-505-272-8111    sreinh@salud.unm.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27701
Contact: Melissa Harward    919-668-3910    Melissa.Harward@duke.edu   
Contact: Chi Hornik    919.970.6680    chi.dang@duke.edu   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kimberly Grzesek    503-494-2797    grzesek@ohsu.edu   
Contact: Sarah Craven    1-503-418-6676    cravens@ohsu.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: John Costello, MD    843-792-9570    costello@musc.edu   
Contact: Andrew Atz, MD    843-876-1698    atzam@musc.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jennifer King, MD    615-963-1302    jennifer.c.king@vumc.org   
Contact: Diana Coman    1-615-875-9700    diana.l.coman@vumc.org   
Sponsors and Collaborators
Christoph P Hornik, MD MPH
The EMMES Corporation
Investigators
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Principal Investigator: Kanecia Zimmerman Duke Clinical Research Institute

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Responsible Party: Christoph P Hornik, MD MPH, Associate Professor Peds, Duke University
ClinicalTrials.gov Identifier: NCT03427736     History of Changes
Other Study ID Numbers: Pro00088893
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data collected is uploaded into the National Institute of Health data repository (DASH) at the end of the study (de-identified).
Time Frame: Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.
Access Criteria:

In order to have access, researchers have to complete a Data access request. NICHD will review the request and either approve or deny it. IRB approval must be obtained by the researcher to access the data.

https://dash.nichd.nih.gov/Resource/DataRequestChecklist

URL: https://dash.nichd.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anesthetics
Ketamine
Analgesics
Hydromorphone
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics