IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 2 - 18 |
| Updated: | 4/17/2018 |
| Start Date: | May 1, 2018 |
| End Date: | May 1, 2019 |
| Contact: | Zebulon Timmons, MD |
| Email: | ztimmons@phoenixchildrens.com |
| Phone: | 602-933-1910 |
IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures. Timmons Z MD, Feudale B MD Children Presenting to the ED With Distal Forearm Extremity Fractures Often Require Re-alignment Under Conscious Sedation. The Objective of This Study is to Evaluate the Sedative, and Analgesic Effects of Intranasal (IN) Dexmedetomidine (DEX) Who Undergo Conscious Sedation for Reduction of Closed Distal Forearm Fractures When Compared to Those Receiving the Standard of Care Intravenous (IV) Ketamine
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.
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.
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.
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.
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
We found this trial at
1
site
1919 E Thomas Rd
Phoenix, Arizona 85006
Phoenix, Arizona 85006
(602) 933-1000
Phone: 602-933-1910
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