Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-17
SponsorState University of New York at Buffalo
About this trial
The aim of this study is to evaluate the efficacy of a hematoma block and minimal ketamine pain control or hematoma block and intranasal fentanyl in pediatric patients presenting with distal radius fractures requiring reduction, compared to control of standard full conscious sedation using ketamine.
Eligibility criteria
Qualifiers
Children requiring reduction for distal radius fracture
Children presenting to the emergency department
Children who are ages 3 to 17 years.
Disqualifiers
Pediatric patients <3 years old
Adult patients (i.e. ages 18 or up)
Pediatric patients with injury patterns that are not amenable to hematoma block.
Children who are not a candidate for sedation related to BMI > 95%tile for age, ASA class > 2, Mallampati score > 2, and pregnant patients
Trial design
Treatments tested in this trial
- Ketamine + Lidocaine
- Ketamine group
- Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov