Using intranasal dexmedetomidine and ketamine for sedation in children with fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• London Health Sciences Centre
  London, Ontario, Canada Recruiting
• 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
• 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
• Email: naveen.poonai@lhsc.on.ca
• Phone: 5196858500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.