Investigating the effects of dexamethasone on recovery after spinal surgery for scoliosis
The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis
This study is testing whether giving adolescents with scoliosis a single or multiple doses of dexamethasone after spinal surgery can help them recover better and reduce the need for pain medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05561725 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of perioperative dexamethasone on postoperative outcomes in adolescents undergoing posterior spinal fusion for adolescent idiopathic scoliosis. Participants will be randomly assigned to receive either standard care with a single dose of dexamethasone or a regimen of multiple doses of dexamethasone following surgery. The study will assess various outcomes including postoperative pain management, nausea, and length of hospital stay. Conducted at Children's Healthcare of Atlanta Egleston, this research seeks to optimize recovery and minimize opioid use in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-18 with adolescent idiopathic scoliosis scheduled for posterior spinal fusion.
Not a fit: Patients with congenital or syndromic scoliosis, adults over 18, pregnant women, prisoners, or those with systemic fungal infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative care and reduced reliance on opioid medications for adolescents undergoing spinal surgery.
How similar studies have performed: While the use of steroids in postoperative care has been explored, this specific investigation into dexamethasone's effects on APR activation in adolescent scoliosis surgery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia
- Children Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Nicholas Fletcher, MD — Associate Professor
- Study coordinator: Nicholas Fletcher, MD
- Email: nicholas.d.fletcher@emory.edu
- Phone: 404-255-1933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.