TraumaNCT02650154
The Effects of the Anesthetic Ketamine in Young Children Undergoing Procedural Sedation
An observational study of Trauma, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 48 months
- Conditions the study is for
- Trauma
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 48 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
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.
Read the detailed description
The objectives of this study are:
Primary Objective: In otherwise healthy children between 3 and 48 months of age who present to a tertiary care emergency department and receive procedural sedation with ketamine, to determine if there is at least a 50% increase, compared to baseline in the serum concentration of any of the neurotoxicity biomarkers S100B, glial fibrillary acidic protein (GFAP) or neuronal-specific enolase (NSE), 1 to 3 hours after intravenous ketamine administration. The cut-off of 50% is a benchmark value routinely quoted in both animal and human studies, which correlated neurotoxicity biomarker levels with functional outcomes.
Secondary Objectives: In the aforementioned population:
- To determine if at least a 50% increase in the serum concentration of S100B, GFAP or NSE compared to baseline at 6 to 12 hours after intravenous ketamine administration.
- To explore if genotypes relevant to ketamine metabolism and disposition are associated with increased vulnerability to the neurotoxic effects of ketamine.
- To determine the toxic effect of ketamine administration at the cellular level (evidence of sustainable cellular damage and mitochondrial DNA changes).
- Conditions
- Trauma
- Keywords
- sedation, children, infants, ketamine, neurotoxicity
- Medical subject headings
- Wounds and Injuries, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in serum biomarkers of neurotoxicity (neuronal cell apoptosis)
Measured: 1 to 24 hours from ketamine exposure
Secondary outcomes (2)
Ketamine-induced mitochondrial damage
Peripheral blood cells we be tested for for mitochondrial damage (changes in biomass and mtDNA) post ketamine exposure. Isolated lymphocytes from pre- and post-ketamine exposure blood samples from each patient will be split into two pools analysed for changes to mitochondrial content and mtDNA damage. The first pool will be stained with mitochondrial membrane potential-specific dye (TMRM) and imaged to reveal changes in mitochondrial morphology and function. DNA will be isolated from the second pool and probed for both cellular mitochondrial content and mtDNA damage using quantitative PCR (Polymerase Chain Reaction).
Measured: 1-24 hours from ketamine exposure
Pharmacogenetics role in ketamine toxicity
In each patient we will determine the allele distribution (proportions/percentages) of polymorphic genes associated with the metabolism of ketamine.
Measured: 1-24 hours from ketamine exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startAug 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Yaron Finkelstein, The Hospital for Sick Children
- Investigators
- Yaron Finkelstein, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650154
- Sponsor's protocol ID
- REB1000033567
- Status last verified
- Oct 2016
- First submitted
- 5 Jan 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Anesthetic Ketamine in Young Children Undergoing Procedural Sedation
- ClinicalTrials.gov ID
- NCT02650154
- Acronym / sponsor ID
- REB1000033567
- Conditions
- Trauma
- Keywords
- sedation, children, infants, ketamine, neurotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Aug 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objectives of this study are:
Primary Objective: In otherwise healthy children between 3 and 48 months of age who present to a tertiary care emergency department and receive procedural sedation with ketamine, to determine if there is at least a 50% increase, compared to baseline in the serum concentration of any of the neurotoxicity biomarkers S100B, glial fibrillary acidic protein (GFAP) or neuronal-specific enolase (NSE), 1 to 3 hours after intravenous ketamine administration. The cut-off of 50% is a benchmark value routinely quoted in both animal and human studies, which correlated neurotoxicity biomarker levels with functional outcomes.
Secondary Objectives: In the aforementioned population:
- To determine if at least a 50% increase in the serum concentration of S100B, GFAP or NSE compared to baseline at 6 to 12 hours after intravenous ketamine administration.
- To explore if genotypes relevant to ketamine metabolism and disposition are associated with increased vulnerability to the neurotoxic effects of ketamine.
- To determine the toxic effect of ketamine administration at the cellular level (evidence of sustainable cellular damage and mitochondrial DNA changes).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase in serum biomarkers of neurotoxicity (neuronal cell apoptosis)
Time frame: 1 to 24 hours from ketamine exposure
2 secondary outcomes
Ketamine-induced mitochondrial damage
Time frame: 1-24 hours from ketamine exposure
Pharmacogenetics role in ketamine toxicity
Time frame: 1-24 hours from ketamine exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Finkelstein, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in serum biomarkers of neurotoxicity (neuronal cell apoptosis) (time frame: 1 to 24 hours from ketamine exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.