Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Dexmedetomidine; Ketamine; Pharmaceutical Solutions

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 4-17 years

2. Weighing up to and including 60 kg

3. Painful procedure including one of the following:

• Forearm fracture

• Metacarpal or phalangeal fracture

• Dislocation of a shoulder or elbow

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).

5. Both nares are fully patent.

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 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