CompletedPhase 2ketamine
IN Sub-Dissociative Ketamine vs IN Fentanyl
Sponsored by Wake Forest University Health Sciences
NCT ID
NCT02521415
Target Enrollment
87 participants
Start Date
2015-12
Est. Completion
2016-11
About This Study
This single center, randomized control, double blind trial will prospectively examine the feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain control in the pediatric emergency department setting. The investigators hypothesize that IN ketamine may provide a safe and effective alternative to IN fentanyl for children with suspected, isolated extremity fractures. Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.
Conditions Studied
Interventions
- •ketamine
- •fentanyl
- •ibuprofen or acetaminophen
Eligibility
Age:4 Years - 17 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * single suspected, isolated extremity fracture that requires analgesia Exclusion Criteria: * GCS \< 15 at ED presentation, * reported allergy or adverse reaction to ketamine or fentanyl, * pregnancy, * intoxication, * hypotension (less than 70 mmHg +2x age or less than 90 mm Hg for patients greater than 11 years of age) * weight \> 70 kg * patients receiving opioid analgesia administered prior to arrival * multiply injured patients (injuries to multiple extremities) * aberrant nasal anatomy that precludes IN medications
Study Locations (1)
Carolinas Medical Center Main - Levine Children's Hospital Emergency Department
Charlotte, North Carolina, United States