Conscious Sedation, Distal Radius Fracture
Conditions
Keywords
intranasal dexmedetomidine
Brief summary
The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.
Detailed description
Distal Forearm fractures are often are displaced requiring conscious sedation for closed reduction in the Emergency Department. Our institution's current standard of care consists of IN Fentanyl for baseline control of pain, and for those fractures requiring reduction; typically IV Ketamine is utilized. Ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. Dexmedetomidine (DEX) offers a possible alternative to IV Ketamine. DEX has been used safely in the critical care setting for both pediatrics and adults. It has been well documented as being quite effective in sedation, amnesia and analgesia. Using IN DEX for PED procedural sedation has the potential to obviate the need for IV placement and may offer a better conscious sedation profile than Ketamine with respect to sedation, analgesia, and adverse outcomes. Our overall project would be to assess the efficiency of IN DEX in comparison to IV Ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.
Interventions
DRUGDexmedetomidine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
DRUGKetamine
Evaluate sedative and analgesic effects of Intravenous Ketamine
Sponsors
Phoenix Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a feasibility pilot study, and as such, will be non-blinded, and utilize a convenience sample of children aged 2-18 years old requiring closed reduction under conscious sedation for distal forearm fractures. 20 children recruited in IN Dex arm and 20 children in Ketamine arm
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment.
Exclusion criteria
1. Under age 2 years old or patients \> 18 years old 2. Multiple Fractures 3. Significant multisystem trauma 4. Glasgow Coma Scale (GCS \< 15) 5. Complex fractures that aren't deemed reducible in ED 6. Reported Allergy to Alpha -2-agonists 7. Pregnancy 8. Intoxication 9. Baseline Hypotension as \< 70mm Hg + 2 x age or \< 90mm Hg for patients \> 11 years of age 10. Patients with prior reductions attempted at outside facilities 11. Aberrant nasal anatomy that precludes IN medications 12. Chronic Health issues that can affect DEX metabolism 13. History of adverse reactions to anesthesia 14. Patients transferred from outside facilities 15. Open fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine | 12 months | The sedative effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation via the Michigan Sedation Scoring (MSS) system. |
| Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine | 12 months | The analgesic effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation using either the Wong-Baker scale (FACES) or Visual Analogue Scale (VAS) depending on patient age and developmental status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare each sedation technique for length of ED stay | 12 months | Time in minutes and seconds from presentation to ED to discharge |
| Compare each sedation technique for need for additional doses of medications for analgesia or sedation | 12 months | Will measure if any unplanned doses of sedatives or analgesics are required in either treatment arm. |
| Compare each sedation technique for Vital sign abnormalities | 12 months | Review vital signs following administration of either study drug to see if any vital signs were abnormal. Abnormal vital signs will be defined as hear rate, respiratory rate, or blood pressure above or below one standard deviation for age derived norms. |
| Compare each sedation technique for time to sedation onset | 12 months | Time in minutes and seconds from administration of sedative agent until Michigan Sedation Scoring (MSS) is 3 or higher. |
| Compare each sedation technique for rate of vomiting | 12 months | Describe the incidence (yes/no) of vomiting at any point after administration of either study drug to ED discharge. |
| Compare each sedation technique for procedural success rate | 12 months | Describe the successful reduction of orthopedic injuries in each study arm. Successful reduction defined as patient able to be discharged and not requiring admission, surgery, or secondary reduction attempts. |
| Compare each sedation technique for patient family satisfaction | 12 months | Describe the family satisfaction with each conscious sedation technique. Measured by brief survey given to the family upon consent for the study. |
| Compare each sedation technique for need for respiratory interventions | 12 months | Measure if any respiratory interventions were required during the patient's ED stay. Respiratory interventions defined as need for oxygen by any device. |
| Compare each sedation technique for length of sedation | 12 months | Time in minutes and seconds from when Michigan Sedation Scoring (MSS) is 3 or higher until MSS is less than 3. |
Countries
United States
Outcome results
None listed