Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03466242
Study type Interventional
Source Phoenix Children's Hospital
Contact Zebulon Timmons, MD
Phone 602-933-1910
Email ztimmons@phoenixchildrens.com
Status Not yet recruiting
Phase Early Phase 1
Start date May 1, 2018
Completion date May 1, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05736068 - Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia? N/A
Completed NCT04554472 - Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Completed NCT03613922 - Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures N/A
Completed NCT01823692 - Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction Phase 2
Completed NCT02286661 - Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius N/A
Completed NCT01062997 - Volar Locked Plating Versus Bridging External Fixation N/A
Not yet recruiting NCT04100317 - Spanning Bridged Plate in Comminuted Distal Radius Fractures
Recruiting NCT04976335 - Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair N/A
Completed NCT03635060 - Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating N/A
Not yet recruiting NCT05095415 - Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting N/A
Terminated NCT02744352 - Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair N/A
Completed NCT01778673 - Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study N/A
Completed NCT05558306 - Radiological vs Clinical Outcome in DRF N/A
Active, not recruiting NCT03349216 - Bier's Block Versus Systemic Analgesia Phase 2
Completed NCT04357470 - Manual Dexterity in Ulnar Styloid Fracture Patients N/A
Recruiting NCT02957240 - Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures N/A
Completed NCT03240471 - Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization N/A
Terminated NCT04089709 - Well-arm Exercise in Distal Radius Fractures N/A
Completed NCT05623865 - The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures. N/A
Enrolling by invitation NCT04632745 - A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly N/A