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Trial record 1 of 1 for:    NCT03427736
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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 : November 13, 2020
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
Kanecia Zimmerman, MD MPH, Duke University

Tracking Information
First Submitted Date February 2, 2018
First Posted Date February 9, 2018
Last Update Posted Date November 13, 2020
Actual Study Start Date December 13, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2018)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anesthetics and Analgesics in Children
Official Title Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
Brief Summary The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
Detailed Description This is a research study to find out what the side effects are of certain drugs that are commonly used for pain and to put people to sleep for surgery. 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. Examples of current and upcoming anesthetics and analgesics include, but are not limited to: hydromorphone (Dilaudid), ketorolac (Toradol), methadone and ketamine.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition
  • Anesthesia
  • Pain
Intervention
  • Drug: Ketorolac Tromethamine
    IV ketorolac will be given per standard of care, not prescribed for this study
    Other Name: Toradol
  • Drug: Hydromorphone
    IV Hydromorphone will be given per standard of care, not prescribed for this study
    Other Names:
    • Hydromorphone hydrochloride
    • Dilaudid
Study Groups/Cohorts Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
Interventions:
  • Drug: Ketorolac Tromethamine
  • Drug: Hydromorphone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 8, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Christie Milleson 919-668-6055 christie.milleson@duke.edu
Contact: Phyllis Kennel 919-668-9958 phyllis.kennel@duke.edu
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03427736
Other Study ID Numbers Pro00088893
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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/
Responsible Party Kanecia Zimmerman, MD MPH, Duke University
Study Sponsor Kanecia Zimmerman, MD MPH
Collaborators The Emmes Company, LLC
Investigators
Principal Investigator: Kanecia Zimmerman Duke Clinical Research Institute
PRS Account Duke University
Verification Date November 2020