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Postoperative Dexamethasone for Scoliosis

Phase 4

Recruiting

Led By Nicholas Fletcher, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately post surgery, 24 hours post-surgery and 48 hours post-surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study whether using dexamethasone can minimize the need for opioids and enhance mobility and recovery following posterior spinal fusion for AIS.

Who is the study for?

This trial is for young people aged 10-18 with a type of scoliosis called AIS, who are having spine surgery (PSF) by Dr. Fletcher at Children's Healthcare of Atlanta Egleston. It's not for those with other types of scoliosis, pregnant women, adults over 18, prisoners, or anyone with systemic fungal infections.

What is being tested?

The study compares standard care to an enhanced dexamethasone treatment after spine surgery in adolescents. The control group gets one dose during surgery; the test group receives additional doses every 8 hours post-surgery to see if it helps reduce pain and nausea and shortens hospital stays.

What are the potential side effects?

Dexamethasone may cause side effects like increased blood sugar levels, stomach irritation, mood swings, insomnia and increase infection risk. Long-term use can lead to more serious issues but this study involves short-term dosing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately post surgery, 24 hours post-surgery and 48 hours post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately post surgery, 24 hours post-surgery and 48 hours post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post surgery, 24 hours post-surgery and 48 hours post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

C-reactive protein

Changes in Interleukin-6

Secondary study objectives

Morphine

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DexamethasoneExperimental Treatment1 Intervention

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.

Group II: Standard of Care: ControlActive Control1 Intervention

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.

Do I qualify?Apply below to find out