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New treatment option for Fracture
Official title Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation
ClinicalTrials.gov ID: NCT04195256
What this study is testing
What is IN Ketodex (D4K2)?
IN Ketodex (D4K2) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fracture.
Also referred to as Ketamine+Dexmedetomidine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- General Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Deemed by treating physician to require procedural sedation Specific criteria
- Children presenting to the paediatric EDs of participating sites age 2-17 years
You likely can't join if
- Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm;
- Suspected globe rupture;
- Concomitant traumatic brain injury with intracranial hemorrhage;
- Uncontrolled hypertension;
- Nasal bone deformity or septal deviation;
- Poor English or French fluency in the absence of native language interpreter;
See the full eligibility criteria
- General Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Deemed by treating physician to require procedural sedation Specific criteria
- Children presenting to the paediatric EDs of participating sites age 2-17 years
- Weighing up to and including 100 kg
- One of the following injuries:
- Closed forearm fracture
- Metacarpal or phalangeal fracture
- Dislocation of a shoulder or elbow
- Type II supracondylar fracture
- Expected to not require more than one dose of IV sedative medication if they were not in the trial (as determined by the procedure physician and not including cast or splint application).
- Both nares are fully patent
- Physician plans to sedate patient
- Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm;
- Suspected globe rupture;
- Concomitant traumatic brain injury with intracranial hemorrhage;
- Uncontrolled hypertension;
- Nasal bone deformity or septal deviation;
- Poor English or French fluency in the absence of native language interpreter;
- American Society of Anesthesiologists (ASA) class 3 or greater;
- Previous diagnosis of schizophrenia or active psychosis as per the treating physician
- Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction;
- More than one fracture or dislocation requiring reduction;
- Hemodynamic compromise as per the treating physician;
- Glasgow coma score \< 15;
- Previous sedation with ketamine or hematoma block within 24 hours;
- Fracture is comminuted or associated with a dislocation;
- Participant has undergone a hematoma block within 24 hours;
- Obstructive sleep apnea
- Previous enrollment in the trial;
- Suspected pregnancy
- Congenital heart disease or known cardiac dysrhythmia
- Known or suspected hepatic impairment
- Known renal insufficiency
- Uncorrected mineralocorticoid deficiency
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Winnipeg, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada; Winnipeg, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.