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Low-Dose Dexmedetomidine for Postoperative Pain in Scoliosis

Phase 4
Waitlist Available
Led By Nichole M Doyle, MD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours post-operatively
Awards & highlights

Summary

This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.

Who is the study for?
This trial is for adolescents with idiopathic scoliosis who are having a spinal fusion surgery involving at least five levels of both thoracic and lumbar spine. It's not open to those who don't meet these specific surgical and diagnostic criteria.
What is being tested?
The study is testing if low-dose dexmedetomidine added to standard pain management after surgery can reduce the need for narcotics and lessen side effects in teens with scoliosis undergoing spinal fusion.
What are the potential side effects?
Dexmedetomidine may cause low blood pressure, slow heart rate, dry mouth, nausea, or drowsiness. However, since it's used here in low doses as part of pain management post-surgery, side effects might be milder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid consumption
Secondary study objectives
Incidence of side effects (nausea, vomiting, pruritus)
Patient safety

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
Placebo Group
Group I: DexmedetomidineExperimental Treatment1 Intervention
Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol
Group II: ControlPlacebo Group1 Intervention
Patient receives normal saline infusion in addition to normal post-operative pain management protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1980

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
251 Previous Clinical Trials
936,049 Total Patients Enrolled
Nichole M Doyle, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City
~107 spots leftby Jul 2026
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