Perioperative Steroid Dosing on the APR in AIS
Completed · Phase 4 · Has a placebo group
Conditions studied: Adolescent Idiopathic Scoliosis (AIS)
In brief
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.
Key facts
- Study ID
- NCT05561725
- Run by
- Emory University
- People needed
- 42
- Starts
- 2023-01-03
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients ages 10-18 with AIS who are undergoing a PSF performed by Dr. Nicholas Fletcher at Children's Healthcare of Atlanta Egleston will be considered eligible for the study
You may not qualify if…
- Patients outside the inclusion parameters or with congenital or syndromic scoliosis
- Adults > 18 years old
- Pregnant women
- Prisoners
- Patients with systemic fungal infections
Where it is running
- Children Healthcare of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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