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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
C-reactive protein
Changes in Interleukin-6
Secondary outcome measures
Morphine
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,482 Total Patients Enrolled
Nicholas Fletcher, MDPrincipal InvestigatorAssociate Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a fungal infection in my body.I am older than 18 years.I am 10-18 years old, have AIS, and am getting a PSF by Dr. Fletcher at Egleston.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care: Control
- Group 2: Dexamethasone
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who can sign up to partake in this clinical experiment?
"In order to be accepted, applicants must have androgen-insensitivity syndrome and fall in the 10 to 18 age range. Currently, 50 participants are sought after for this trial."
Answered by AI
Are there any unfilled slots for volunteers in this trial?
"Based on the clinicaltrials.gov records, this trial is not accepting participants at present. The study was published on Sept 1st 2023 and last modified by researchers around September 29th 2022. Nonetheless, there are presently 75 other trials recruiting patients in total."
Answered by AI
Has the U.S. Food and Drug Administration given its seal of approval to Dexamethasone?
"There is substantial clinical evidence that supports the safety of dexamethasone, and thus, it was graded with a 3 on our internal scale."
Answered by AI
Is participation in this trial restricted to individuals under the age of 45?
"This clinical trial only admits participants between the ages of 10 to 18. There are 67 trials for minors and 14 studies targeting individuals over 65 years old."
Answered by AI
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