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RECRUITING
NCT05561725
PHASE4

Perioperative Steroid Dosing on the APR in AIS

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion. This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.

Official title: The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-01-03

Completion Date

2026-03

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone postoperative

Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional (8mg doses) administered at 8-hour intervals following surgery for a total of 4 doses. All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

DRUG

Standard of Care

Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. No sham medication will be utilized for control subjects. All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

Locations (1)

Children Healthcare of Atlanta

Atlanta, Georgia, United States