Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation

Recruiting Phase 2 Phase 3 Interventional Study
Fracture Dislocation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Naveen Poonai · Other
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About This Trial
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). Intrav…
Trial Locations
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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 present…
Contacts

Naveen Poonai, MD

5196858500

naveen.poonai@lhsc.on.ca

CONTACT

Kamary Coriolano, PhD

5196858500

kamary.coriolanodasilva@lhsc.on.ca

CONTACT