Anesthetics and Analgesics in Children (ANA01)

• ClinicalTrials.gov Identifier: NCT03427736
• Recruitment Status: Recruiting
• First Posted: February 9, 2018
• Last Update Posted: November 13, 2020
• Sponsor: Kanecia Zimmerman, MD MPH
• 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
• 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

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

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