An Early Phase 1 interventional study of Dexmedetomidine and Ketamine in Conscious Sedation and Distal Radius Fracture, sponsored by Phoenix Children's Hospital. Withdrawn at 1 site in United States. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Phoenix Children's Hospital · Early Phase 1, Interventional, and Treatment
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Among 72 studies in Wrist Fractures with a site in United States — 12 open to participants now, 19 under way, 1 of them phase 3. Wrist Fractures · United States.
Among the 72 studies in Wrist Fractures with a site in United States, this one is the 60th largest by enrollment of the 64 interventional ones that give a count, is one of 2 that started in 2017, is one of 7 in phase 1, and was the 30th registered.
330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.
Browse Wrist Fractures studies →12 of the 72 studies in Wrist Fractures with a site in United States are open now. Recruiting first, the newest first:
Nemours Children's Clinic · Sites in United States
Ages 3–18
George Washington University · Sites in United States
Ages 18–110 · Healthy volunteers
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+ · Healthy volunteers
Hand Surgery Associates LLC · Sites in United States
Ages 18+
University of Kansas Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 43 Wrist Fractures studies recruiting now, 20 (47%) set no upper age limit and 15 (35%) stop at 75 or younger; 7 take children under 18; 6 take healthy volunteers.
This study: 2 Years to 18 Years · all sexes · healthy volunteers too.
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72 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 52 across the 64 interventional studies, 74 across the 7 observational. Of the 39 that completed or were terminated, 14 (36%) have results posted.
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3 of 72 have an industry lead sponsor. The 10 most frequent:
Phoenix Children's Hospital is the lead sponsor of 42 studies on the registry; 8 are open to participants now.
Phoenix Children's Hospital has 1 study filed under Wrist Fractures — fewer than ten, so there is no comparison to draw.
6 of the studies in Wrist Fractures with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04113044AO Innovation Translation CenterGo Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® | 2026-12-31 |
| NCT05086224University of UtahHematoma Block Versus Bier Block for Closed Fracture Reduction | 2027-07 |
| NCT04976335University of Colorado, DenverQuantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair | 2027-07 |
| NCT06251206George Washington UniversityImpact of Early ADL Education on Outcomes Post DRF ORIF | 2027-08 |
| NCT02346929Beth Israel Deaconess Medical CenterHematoma Block for Distal Radius Fracture | 2027-08 |
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Among the 72 studies in Wrist Fractures with a site in United States, from their registry updates:
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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.
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.
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:
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)
Drug: Dexmedetomidine
Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)
Drug: Ketamine
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
Also known as: Precedex
Evaluate sedative and analgesic effects of Intravenous Ketamine
Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine
The sedative effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation via the Michigan Sedation Scoring (MSS) system.
Time frame: 12 months
Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine
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
Time frame: 12 months
Compare each sedation technique for time to sedation onset
Time in minutes and seconds from administration of sedative agent until Michigan Sedation Scoring (MSS) is 3 or higher.
Time frame: 12 months
Compare each sedation technique for length of sedation
Time in minutes and seconds from when Michigan Sedation Scoring (MSS) is 3 or higher until MSS is less than 3.
Time frame: 12 months
Compare each sedation technique for length of ED stay
Time in minutes and seconds from presentation to ED to discharge
Time frame: 12 months
Compare each sedation technique for need for additional doses of medications for analgesia or sedation
Will measure if any unplanned doses of sedatives or analgesics are required in either treatment arm.
Time frame: 12 months
Compare each sedation technique for Vital sign abnormalities
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.
Time frame: 12 months
Compare each sedation technique for need for respiratory interventions
Measure if any respiratory interventions were required during the patient's ED stay. Respiratory interventions defined as need for oxygen by any device.
Time frame: 12 months
Compare each sedation technique for rate of vomiting
Describe the incidence (yes/no) of vomiting at any point after administration of either study drug to ED discharge.
Time frame: 12 months
Compare each sedation technique for procedural success rate
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.
Time frame: 12 months
Compare each sedation technique for patient family satisfaction
Describe the family satisfaction with each conscious sedation technique. Measured by brief survey given to the family upon consent for the study.
Time frame: 12 months
Plan to share: Undecided
Start is estimated for Jan 2017; primary completion for Jan 2020, 36 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Phoenix Children's Hospital