Low-Dose Dexmedetomidine for Postoperative Pain in Scoliosis

Recruiting in Palo Alto (17 mi)

Overseen byNichole M Doyle, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Children's Mercy Hospital Kansas City

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am having a spine surgery that involves both my upper and lower back.

I have been diagnosed with idiopathic scoliosis.

Treatment Details

Interventions

Dexmedetomidine (Alpha-2 Adrenergic Agonist)

Trial OverviewThe 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.

Participant Groups

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