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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Children Healthcare of Atlanta
RECRUITING
Atlanta
Contact Information
Primary
Nicholas Fletcher, MD
nicholas.d.fletcher@emory.edu
404-255-1933
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Active_comparator: Standard of Care: Control
Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups.~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.
Experimental: Dexamethasone
Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups.~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.
Sponsors
Leads: Emory University

This content was sourced from clinicaltrials.gov