CompletedN/Aketamine

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

Sponsored by The Hospital for Sick Children

NCT ID
NCT02650154
Target Enrollment
70 participants
Start Date
2013-08
Est. Completion
2016-02

About This Study

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 Studied

Trauma

Eligibility

Age:3 Months - 48 Months
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

1\. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. Child who has received procedural sedation/ or surgery under general anesthesia in the past 30 days.
4. 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.
5. A child who has suffered traumatic head injury concomitantly or in the previous 30 days
6. 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.
7. 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.

Study Locations (1)

The Hospital for Sick Children
Toronto, Ontario, Canada

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

Find recruiting trials
Data Source
ClinicalTrials.gov

Last updated from source