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

NCT03466242 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Conscious Sedation
  • Distal Radius Fracture

Interventions

DRUG

Dexmedetomidine

Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine

DRUG

Ketamine

Evaluate sedative and analgesic effects of Intravenous Ketamine

Sponsors & Collaborators

  • Phoenix Children's Hospital

    lead OTHER

Principal Investigators

  • Zebulon Timmons, MD · Phoenix Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-01-01
Completion
2020-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466242 on ClinicalTrials.gov