This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine
and intranasal fentanyl in children presenting to the Emergency Department with acute
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02778880
Ages eligible for Study
8 Years to 17 Years
Genders eligible for Study
Accepts Healthy Volunteers
8 years to 17 years (up to the 18th birthday)
Presenting to emergency department with one or more extremity injuries
Visual analog scale score 35 mm or greater
Parent or legal guardian present and willing to provide written consent
Received narcotic pain medication prior to arrival
Evidence of significant head, chest, abdomen, or spine injury
Glasgow coma score less than 15 or unable to self report pain score
Nasal trauma or aberrant nasal/airway anatomy
Allergy to ketamine, fentanyl or meperidine
Non-English speaking parent and/or child
History of psychosis
Postmenarchal female without a urine or serum assay documenting the absence of pregnancy
Brought in my juvenile detention center or in police custody
All locations for NCT02778880
United States (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
View full eligibility
Tris trial is registered with FDA with number: NCT02778880. The sponsor of the trial is Children's Hospital Medical Center, Cincinnati and it is looking for 90 volunteers for the current phase.
Official trial title: A Randomized Controlled Trial of Intranasal Sub-dissociative Dosing of Ketamine Compared to Intranasal Fentanyl for Treatment of Pain Associated With Acute Extremity Injuries in Children
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