Pediatrics Clinical Trial
Official title:
Systemic Absorption of Lidocaine After Ultrasound Guided Hematoma Block for Reduction of Different Types of Pediatric Distal Radius Fractures
Verified date | December 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will measure in children how much numbing medicine, lidocaine, is absorbed into the bloodstream after it is injected into a blood clot (hematoma) around a forearm fracture for pain control when the broken bone is moved back into place (fracture reduction). This is called a hematoma block and is commonly used in the Emergency Unit. To help with anxiety and to add additional pain control, nitrous oxide (laughing gas) is given while the lidocaine hematoma block is placed and continued during the fracture reduction. Advantages of using this technique for pain control instead of an intravenous anesthetic such as ketamine include faster recovery and discharge home, and longer pain control. Of concern, if too much lidocaine is absorbed into the bloodstream, seizures and irregular heart beating may occur. Bloodstream concentrations of lidocaine after a hematoma block have been measured in only one study of 8 adults and found to be at significant but safe levels. No study has been published in children to measure bloodstream lidocaine levels when a hematoma block is used. Because children's bones are still growing and more metabolically active than adult bones, the investigators believe it is important to determine whether lidocaine blood levels in children are also at safe levels when using a standard lidocaine hematoma block for reduction of fractures. The investigators also want to determine whether bloodstream lidocaine levels correlate with type of fracture. The investigators also aim to determine if there is a difference in absorption pattern between different types of distal radius fractures, if there is a correlation between fracture type and systemic lidocaine absorption, and if there is a correlation between fracture type and ability to provide adequate pain and sedation control with lidocaine hematoma block/inhaled nitrous combination. The investigators believe blood lidocaine levels after hematoma block in children will peak at safe levels, but will be higher than those observed in adults.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility | Inclusion Criteria: - ASA status class 1 or 2 - Ages 5-17 - Parent/guardian is present Exclusion Criteria: - Open fracture - Previous attempt at reduction - Multiple other injuries - Physeal (growth plate) fractures - Volar displacement of the distal fracture fragment - Delayed presentation (>48 hrs from injury) - Concern for significant neurovascular injury - Refracture through a healing fracture - History of adverse effect from lidocaine or nitrous oxide - Active psychosis - Non English speaking parents - Liver disease - Cardiac disease - Abnormal bones such as osteogenesis imperfecta or osteopenia from lack of use - Developmental abnormalities |
Country | Name | City | State |
---|---|---|---|
United States | Saint Louis Children's Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Bear DM, Friel NA, Lupo CL, Pitetti R, Ward WT. Hematoma block versus sedation for the reduction of distal radius fractures in children. J Hand Surg Am. 2015 Jan;40(1):57-61. doi: 10.1016/j.jhsa.2014.08.039. Epub 2014 Oct 11. — View Citation
Blasier RD. Anesthetic considerations for fracture management in the outpatient setting. J Pediatr Orthop. 2004 Nov-Dec;24(6):742-6. doi: 10.1097/00004694-200411000-00027. No abstract available. — View Citation
Cote CJ, Wilson S. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures. Pediatr Dent. 2019 Jul 15;41(4):26E-52E. — View Citation
Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897. — View Citation
Kennedy RM, Porter FL, Miller JP, Jaffe DM. Comparison of fentanyl/midazolam with ketamine/midazolam for pediatric orthopedic emergencies. Pediatrics. 1998 Oct;102(4 Pt 1):956-63. doi: 10.1542/peds.102.4.956. — View Citation
Luhmann JD, Schootman M, Luhmann SJ, Kennedy RM. A randomized comparison of nitrous oxide plus hematoma block versus ketamine plus midazolam for emergency department forearm fracture reduction in children. Pediatrics. 2006 Oct;118(4):e1078-86. doi: 10.1542/peds.2005-1694. Epub 2006 Sep 11. — View Citation
Meinig RP, Quick A, Lobmeyer L. Plasma lidocaine levels following hematoma block for distal radius fractures. J Orthop Trauma. 1989;3(3):187-91. doi: 10.1097/00005131-198909000-00001. — View Citation
Naranje SM, Erali RA, Warner WC Jr, Sawyer JR, Kelly DM. Epidemiology of Pediatric Fractures Presenting to Emergency Departments in the United States. J Pediatr Orthop. 2016 Jun;36(4):e45-8. doi: 10.1097/BPO.0000000000000595. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma Lidocaine Levels | Measured concentrations of plasma lidocaine levels for subjects undergoing lidocaine hematoma block for their distal radius fracture reduction. | Serial plasma lidocaine levels will be measured during a single subject's distal forearm fracture reduction, to be measured over the course of 60 minutes form the injection of lidocaine into the hematoma block. |
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