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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full ketamine sedation | Active Comparator | Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction |
|
| Hematoma block/minimal ketamine pain control | Active Comparator | Including group of patients treated with hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction in pediatric patients requiring reduction |
|
| hematoma block/intranasal fentanyl | Active Comparator | Including control group of patients treated with intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine + Lidocaine | Drug | Including 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 hour after fracture reduction is complete on the day of the procedure/study visit. |
| 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. | 1 hour after fracture reduction is complete on the day of the procedure/study visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Lutnick Lutnick, MD | Contact | (716) 323-2100 | ellenlut@buffalo.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oshei Children's Hospital | Recruiting | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10901305 | Background | McCarty EC, Mencio GA, Walker LA, Green NE. Ketamine sedation for the reduction of children's fractures in the emergency department. J Bone Joint Surg Am. 2000 Jul;82-A(7):912-8. doi: 10.2106/00004623-200007000-00002. | |
| 25834964 | Background | Disel NR, Yilmaz HL, Sertdemir Y, Yesilagac H, Avci A. Etomidate Versus Ketamine: Effective Use in Emergency Procedural Sedation for Pediatric Orthopedic Injuries. Pediatr Emerg Care. 2016 Dec;32(12):830-834. doi: 10.1097/PEC.0000000000000373. |
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IPD will not be shared. This is a single institution study; results will be shared after de-identification/analysis in the form of publication/presentation.
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|
| Ketamine group | Drug | Including 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) | Drug | Including 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 |
|
|
| 29182126 | Background | Jordan RW, Aquilina A, Westacott DJ, Cooke S. A comparison of ketamine sedation and general anaesthesia for manipulation of paediatric forearm fractures. Acta Orthop Belg. 2016 Dec;82(4):836-842. |
| 28877328 | Background | Morrison T, Carender C, Kilbane B, Liu RW. Procedural Sedation With Ketamine Versus Propofol for Closed Reduction of Pediatric Both Bone Forearm Fractures. Orthopedics. 2017 Sep 1;40(5):288-294. doi: 10.3928/01477447-20170824-01. Epub 2017 Sep 7. |
| 34459117 | Background | Kwong A, Aldridge ES, Jayawardana R, Brookwick A, Miller J, Buntine PG. Length of stay outcomes in patients receiving ketamine sedation versus Bier's block anaesthesia for procedural closed fracture reduction: A retrospective audit of paediatric emergency department patients. Emerg Med Australas. 2022 Feb;34(1):73-77. doi: 10.1111/1742-6723.13844. Epub 2021 Aug 29. |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008012 | Lidocaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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