🏛️ Verified NIH Record • Updated 2024-11-01

Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation (NCT04195256)

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

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Naveen Poonai

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (23 items).

Location: Stollery Children's Hospital — Edmonton, Alberta

Age range: 2 Years to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • EXCLUSION CRITERIA
  • Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm;
  • Suspected globe rupture;
  • Concomitant traumatic brain injury with intracranial hemorrhage;
  • Uncontrolled hypertension;
  • Nasal bone deformity or septal deviation;
  • Poor English or French fluency in the absence of native language interpreter;
  • American Society of Anesthesiologists (ASA) class 3 or greater;
  • Previous diagnosis of schizophrenia or active psychosis as per the treating physician
  • Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction;
  • More than one fracture or dislocation requiring reduction;
  • Hemodynamic compromise as per the treating physician;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

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

📞 Contact the Study Coordinator

Phone: (519) 685-8500

Email: naveen.poonai@lhsc.on.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗