Perioperative Steroid Dosing on the APR in AIS
The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis
Emory University
50 participants
Jan 3, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- 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
Exclusion Criteria5
- Patients outside the inclusion parameters or with congenital or syndromic scoliosis
- Adults > 18 years old
- Pregnant women
- Prisoners
- Patients with systemic fungal infections
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Interventions
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.
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)
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NCT05561725