Phase 2
Completed N=87
IN Sub-Dissociative Ketamine vs IN Fentanyl
Source: ClinicalTrials.gov NCT02521415 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Primary Outcome: Number of Participants With Minor Side Effects and Significant Adverse Events — 0; 0; 41; 25 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome: Number of Participants With Minor Side Effects and Significant Adverse Events |
0; 0; 41; 25; 2; 19 | — |
| SECONDARY Secondary Outcome: Total Dose of Opioid Pain Medication in Morphine Equivalents/kg/Hour |
0.04; 0.05 | — |
Eligibility Criteria
Inclusion Criteria
- single suspected, isolated extremity fracture that requires analgesia
Exclusion Criteria
- GCS 70 kg
- patients receiving opioid analgesia administered prior to arrival
- multiply injured patients (injuries to multiple extremities)
- aberrant nasal anatomy that precludes IN medications
Data sourced from ClinicalTrials.gov (NCT02521415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.