Phase 2 N=87 Randomized Triple-blind Treatment

IN Sub-Dissociative Ketamine vs IN Fentanyl

Bone Fracture

Bottom Line

View on ClinicalTrials.gov: NCT02521415 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Primary Outcome: Number of Participants With Minor Side Effects and Significant Adverse Events — 0; 0; 41; 25 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ketamine (Drug); fentanyl (Drug); ibuprofen or acetaminophen (Drug)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Nov 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

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.