Pain Control Methods for Children with Distal Radius Fractures
Ketamine + Lidocaine
+ Ketamine group
+ Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Agnosia+4
+ Nervous System Diseases
+ Neurologic Manifestations
Treatment Study
Summary
Study start date: August 22, 2025
Actual date on which the first participant was enrolled.This study focuses on finding effective ways to manage pain in children who have broken a specific bone in their wrist, known as a distal radius fracture. The research is important because it explores pain relief options that might be safer or more comfortable than the usual method of full conscious sedation with ketamine. The study is comparing two different combinations of treatments: one using a hematoma block with minimal ketamine and the other using a hematoma block with intranasal fentanyl. The goal is to see which of these methods controls pain effectively while potentially offering an improved experience for young patients. Participants in the study will receive either one of the two new pain control methods or the standard approach with ketamine. A hematoma block, which involves injecting medication directly into the area around the broken bone, is used in both new methods. In one method, this is combined with a small dose of ketamine, and in the other, with a dose of fentanyl delivered through the nose. The study will evaluate how well these methods manage pain by observing the patients and assessing their comfort levels during the treatment process. By comparing these approaches, the study aims to identify the most effective and patient-friendly option for managing pain in children with wrist fractures.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 3 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Children requiring reduction for distal radius fracture * Children presenting to the emergency department * Children who are ages 3 to 17 years. Exclusion Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location