Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ketamine + Lidocaine
DrugIncluding comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
Ketamine group
DrugIncluding comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
DrugIncluding comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Full ketamine sedationActive comparator 1 intervention
Group B: Hematoma block/minimal ketamine pain controlActive comparator 1 intervention
Group C: hematoma block/intranasal fentanylActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain control efficacy
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining Visual Analog Scale (VAS) pain scores for each group to determine pain control efficacy and to compare between groups. This is a numeric pain scale with associated faces to help children determine their pain level, with 0 being "no pain" (with a smiley/happy face) and 10 being "most pain possible" (with a sad/crying face).
Time frame
1 hour after fracture reduction is complete on the day of the procedure/study visit.2
Patient satisfaction scores
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining patient satisfaction scores via a 5-point Likert scale to compare patient satisfaction between groups.
Time frame
1 hour after fracture reduction is complete on the day of the procedure/study visit.Sponsors and contacts
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Source ClinicalTrials.gov