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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
Undergoing a posterior spinal fusion of at least 5 levels with both thoracic and lumbar involvement
Diagnosis of idiopathic scoliosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours post-operatively
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test if adding a small amount of dexmedetomidine to the current pain management plan for teenagers undergoing spinal surgery can help reduce the need for strong painkillers and lessen side effects

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a spine surgery that involves both my upper and lower back.
Select...
I have been diagnosed with idiopathic scoliosis.

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~2050

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
256 Previous Clinical Trials
940,175 Total Patients Enrolled
Nichole M Doyle, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City
~107 spots leftby Jul 2026
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