IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

Distal Radius Fracture Clinical Trial

Official title:
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

Status Not yet recruiting

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

Clinical Trial Details

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

View Details

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
Completed	`NCT05360836` - The Effect of Motor Imagery in Patients With Radius Distal End Fracture	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.