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Alpha-2 Adrenergic Agonist

Intranasal Dexmedetomidine for Conscious Sedation

Phase < 1
Waitlist Available
Led By Zebulon Timmons, MD
Research Sponsored by Phoenix Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion Criteria:Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Eligible Conditions
  • Conscious Sedation
  • Distal Radius Fracture

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine
Forearm
Secondary outcome measures
Compare each sedation technique for Vital sign abnormalities
Compare each sedation technique for length of ED stay
Compare each sedation technique for length of sedation
+6 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intranasal DexmedetomidineExperimental Treatment1 Intervention
Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)
Group II: IV KetamineActive Control1 Intervention
Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor
74 Previous Clinical Trials
5,013,706 Total Patients Enrolled
Zebulon Timmons, MDPrincipal InvestigatorPhoenix Children's Hospital
~5 spots leftby Sep 2025
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