Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation

Launched by NAVEEN POONAI · Dec 9, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help children feel more comfortable during painful procedures, like fixing broken bones. Researchers want to see if using a combination of intranasal dexmedetomidine and ketamine (called IN Ketodex) is just as effective as the commonly used intravenous (IV) ketamine for sedation. This is important because many children find getting an IV very painful, and the goal is to provide sedation without that discomfort.

To be eligible for the trial, children aged 4 to 17 who weigh up to 60 kg and need a specific type of painful procedure (like a forearm fracture or a dislocated shoulder) may participate. Parents will need to sign a consent form, and the child must be able to breathe through both nostrils. Participants can expect to receive either the IN Ketodex or the IV ketamine and will be monitored to see how well each method works. This study aims to improve the overall experience for children and their families during treatment for fractures and dislocations.

Gender

ALL

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