The Effects of the Anesthetic Ketamine in Young Children Undergoing Procedural Sedation

NCT02650154 | Completed

• 1 other identifier: REB1000033567
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In the emergency department (ED), ketamine is a popular anesthetic agent during sedation of children for painful and other short procedures. Sedation for procedures is more commonly used in children than adults, to achieve motion control and cooperation. In children, ketamine offers an ideal choice due to the fact that it is short acting, a highly effective sedative, and preserves cardio-respiratory stability. In the United States, more than one million children per year up to four years of age undergo short procedures requiring anesthestic agents, including ketamine. However, there is mounting concern from animal studies and retrospective human research regarding the safety of ketamine when administered to infants and young children with respect to its potential toxic effects on the developing . Conversely, ketamine has also been suggested as a neuroprotective agent. Prompt investigation and resolution of this issue is urgently required.

Conditions

Trauma

Keywords

sedation; children; infants; ketamine; neurotoxicity

Outcome Measures

Primary Outcomes (1)

• Increase in serum biomarkers of neurotoxicity (neuronal cell apoptosis)

  1 to 24 hours from ketamine exposure

Secondary Outcomes (2)

• Ketamine-induced mitochondrial damage

  1-24 hours from ketamine exposure

• Pharmacogenetics role in ketamine toxicity

  1-24 hours from ketamine exposure

Study Arms (2)

Pre-ketamine group

Blood samples are taken prior to the administration of ketamine.

Post-ketamine group

Blood samples are taken several hours after the administration of ketamine.

Eligibility Criteria

• Age: 3 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All children between the ages of 3 and 48 months who receive intravenous ketamine for procedural sedation in the ED during study enrolment hours will be eligible for recruitment.

You may qualify if:

• \. All children between the ages of 3 and 48 months who receive intravenous ketamine for procedural sedation in the ED during study enrolment hours will be eligible for recruitment.

You may not qualify if:

• Children with contraindications to procedural sedation in the ED according to SickKids (the Hospital for Sick Children) practice guidelines or to ketamine administration will not be considered.
• Parents with an insurmountable language barrier (i.e. does not speak English and are not accompanied by another adult who cannot translate for the parent/caregiver), which prevents informed consent.
• Child who has received procedural sedation/ or surgery under general anesthesia in the past 30 days.
• A child who has received any central nervous system drugs (e.g. anticonvulsants, benzodiazepines) or a known neurotoxic drug (e.g., methotrexate, corticosteroids) concomitantly or in the 30 days preceding the sedation.
• A child who has suffered traumatic head injury concomitantly or in the previous 30 days
• A child who has CNS (Central Nervous System) illnesses or pathologies (e.g., meningitis, near drowning, hypoxic-ischemic brain injury, seizure disorder) in the 30 days prior to sedation, potentially leading to elevated baseline serum biomarkers.
• A child whose parents are considered to be in emotional distress due to the injury or illness of the child by the attending ED physician or where the attending ED physician does not believe it is appropriate to ask the parents for consent.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University of Toronto: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and plasma samples

MeSH Terms

Conditions

Wounds and Injuries; Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Yaron Finkelstein, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 8, 2016
• Study Start: August 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)