INK Feasibility Study

March 23, 2023 updated by: Lawson Health Research Institute

Intranasal Ketamine for Procedural Sedation: a Feasibility Cohort Study

The trial (Intranasal ketamine for procedural sedation in children: a randomized controlled non-inferiority multicenter trial or INK; ReDA 5496; CTO 1545) is being scheduled for launch in Spring 2019. Due to the possibility of failure of the experimental intervention (intranasal ketamine 10 mg/kg), the data safety monitoring board (DSMB) and statistical methods team would like to explore the possibility of developing a stopping rule to prevent patients from being enrolled in a futile trial and conserve resources. In order to get accurate data to develop a statistically robust stopping rule, it is necessary to conduct a cohort study of patients that receive the INK trial's experimental intervention and according to it's protocol. This cohort study will help estimate the chance of adequate sedation and inform the final dosing protocol for the INK trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA) (3, 4). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction (5). However, children rate IV insertion as the most painful hospital experience, second only to the injury itself (6). Intranasal (IN) ketamine may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. Although the proportion of children with adequate sedation using IN ketamine at doses of 9-10 mg/kg has been reported to be at least 75% (9-11), there is the possibility of inadequate sedation because IN ketamine 10 mg/kg has not been used for procedural sedation for fracture reduction. A multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that intranasal (IN) ketamine is non-inferior to intravenous (IV) ketamine is being planned for launch in Spring 2019 and a stopping rule for futility will ensure that patients are not unduly enrolled and that resources are not wasted in a futile trial. Creating of a methodologically rigorous stopping rule depends on the results of a small cohort study to provide a more accurate and informed estimate of the probability of adequate sedation with IN ketamine 10 mg/kg.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • General Criteria

    1. Provision of signed and dated informed consent form
    2. Stated willingness to comply with all study procedures and availability for the duration of the study
    3. Deemed by treating physician to require procedural sedation using ketamine Specific Criteria
    1. Children presenting to the paediatric EDs of participating sites age 7-17 years
    2. Weighing up to and including 80 kg
    3. Distal radius +/- ulna fracture or dislocation of a shoulder, elbow, patella, or digit
    4. Closed reduction expected to take no more than 5 minutes to reduce (as determined by the procedure physician and not including cast or splint application).

Exclusion Criteria:

  • 1) Previous hypersensitivity reaction to ketamine including rash, difficulty breathing, hypotension, apnea, or laryngospasm; 2) Suspected globe rupture; 3) Concomitant traumatic brain injury with intracranial hemorrhage; 4) Uncontrolled hypertension; 5) Nasal bone deformity or nasal obstruction with at least one nare obstructed due to allergic or viral rhinitis, sinusitis, nasal polyps, or septal deviation; 6) Poor English or French fluency in the absence of native language interpreter; 7) American Society of Anesthesiologists (ASA) class 3 or greater; 8) Previous diagnosis of schizophrenia or active psychosis as per the treating physician 9) Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction; 10) Multi-limb trauma; 11) Hemodynamic compromise as per the treating physician; 12) Glasgow coma score < 15; 13) Previous sedation with ketamine within 24 hours; 14) Fracture is comminuted or associated with a dislocation; 15) Participant has undergone a hematoma block within 24 hours; 16) Isolated ulna fracture; 17) Previous enrollment in the trial; 18) Suspected pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intranasal ketamine
Intranasal ketamine 10 mg/kg
Drug: Intranasal ketamine
10 mg/kg single dose in 0.5 mL sprays in each nare separated by 60 seconds

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adequacy of sedation
Time Frame: 1 hour
Dartmouth Operative Conditions Scale (DOCS) score between -2 and +2 for the duration of the closed reduction AND, (ii) No additional IV ketamine is given during closed reduction for the purpose of sedation, AND (iii) The patient did not actively resist, cry, or require physical restraint for completion of the closed reduction.
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 1 hour
Defined as the time recorded in the medical record between triage and discharge in minutes
1 hour
Onset of sedation
Time Frame: 1 hour
This will be defined as the time interval from administration of the first pair of IN sprays to the time when a first DOCS score of between -2 and +2 is achieved post-intervention (minutes)
1 hour
Duration of sedation
Time Frame: 1 hour
This will be defined as the duration of time between the first DOCS score between -2 to +2 post-intervention to the last DOCS score between -2 and +2 post-closed reduction (minutes).
1 hour
Adverse effects
Time Frame: 1 hour
Research nurses will be trained on the recognition and definition of expected and unexpected AEs. AEs will be determined from the medical record and recorded on REDCap. Expected AEs are based on the Quebec guidelines and other practice guidelines. Unpleasant recovery reactions will be recorded by the research nurse using REDCap.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 113103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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