Using intranasal dexmedetomidine and ketamine for sedation in children with fractures

Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children: an Adaptive Randomized Controlled Non-inferiority Multicenter Trial

This study is testing a new way to help kids aged 2-17 feel calm and comfortable during treatment for fractures by using a nasal spray instead of an IV.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 6 sites (Edmonton, Alberta and 5 other locations)
• Trial ID: NCT04195256 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of intranasal dexmedetomidine combined with ketamine for procedural sedation in children aged 2-17 years who require treatment for orthopedic injuries such as fractures and dislocations. The study aims to provide a less painful alternative to intravenous sedation, which can be distressing and technically challenging in pediatric patients. By utilizing intranasal administration, the trial seeks to improve the sedation experience and reduce the need for painful IV insertions. The research builds on previous systematic reviews indicating that intranasal dexmedetomidine may be superior to traditional sedatives.

Who should consider this trial

Good fit: Ideal candidates are children aged 2-17 years presenting with specific orthopedic injuries requiring sedation.

Not a fit: Patients with a history of hypersensitivity to ketamine or dexmedetomidine will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the pain and anxiety associated with procedural sedation in children.

How similar studies have performed: Previous studies have shown promising results for intranasal dexmedetomidine and ketamine, indicating potential for success in this novel approach.

Eligibility criteria

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

Where this trial is running

Edmonton, Alberta and 5 other locations

• Stollery Children's Hospital — Edmonton, Alberta, Canada (Completed)
• BC Children's Hospital — Vancouver, British Columbia, Canada (Completed)
• McMaster Children's Hospital — Hamilton, Ontario, Canada (Completed)
• London Health Sciences Centre — London, Ontario, Canada (Recruiting)
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Withdrawn)
• Winnipeg Children's Hospital — Winnipeg, Ontario, Canada (Completed)

Study contacts

• Principal investigator: Naveen Poonai, MD — Western University
• Study coordinator: Naveen Poonai, MD

Conditions Fracture; Dislocation