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Perioperative Steroid Dosing on the APR in AIS
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.
Conditions:
🦠 Adolescent Idiopathic Scoliosis (AIS)
🗓️ Study Start (Actual) 3 January 2023
🗓️ Primary Completion (Estimated) September 2024
✅ Study Completion (Estimated) September 2024
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * Patients outside the inclusion parameters or with congenital or syndromic scoliosis
    • * Adults \> 18 years old
    • * Pregnant women
    • * Prisoners
    • * Patients with systemic fungal infections
Ages Eligible for Study: 10 Years to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 September 2022
  • First Submitted that Met QC Criteria 29 September 2022
  • First Posted 30 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 September 2023
  • Last Update Posted 3 October 2023
  • Last Verified September 2023
I'm interested ...!!