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โ† Trials
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Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation

RecruitingPhase 2, Phase 3Ages 2 Years - 17 YearsAllNaveen Poonai
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In plain words

What the trial is, and whether it could suit you

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. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed redu

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 Specific criteria 1. Children presenting to the paediatric EDs of participating sites age 2-17 years 2. Weighing up to and including 100 kg 3. One of the following injuries: * Closed forearm fracture * Metacarpal or phalangeal fracture * Dislocation of a shoulder or elbow * Type II supracondylar fracture 4. 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). 5. Both nares are fully patent 6. Physician plans to sedate patient EXCLUSION CRITERIA 1. Previous hypersensitivity reaction to ketamine or dexmedetomidine 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 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. More than one fracture or dislocation requiring reduction; 11. Hemodynamic compromise as per the treating physician; 12. Glasgow coma score \< 15; 13. Previous sedation with ketamine or hematoma block within 24 hours; 14. Fracture is comminuted or associated with a dislocation; 15. Participant has undergone a hematoma block within 24 hours; 16. Obstructive sleep apnea 17. Previous enrollment in the trial; 18. Suspected pregnancy 19. Congenital heart disease or known cardiac dysrhythmia 20. Known or suspected hepatic impairment 21. Known renal insufficiency 22. Uncorrected mineralocorticoid deficiency
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What it tests

  • IN Ketodex (D4K2)
  • IN Ketodex (D3K3)
  • IN Ketodex (D2K4)
  • IV Ketamine
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Where

6 sites
Stollery Children's Hospital
Edmonton, Canada
BC Children's Hospital
Vancouver, Canada
McMaster Children's Hospital
Hamilton, Canada
London Health Sciences Centre
London, Canada
Children's Hospital of Eastern Ontario
Ottawa, Canada
Winnipeg Children's Hospital
Winnipeg, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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