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Medrol for Postoperative Pain

Phase < 1
Waitlist Available
Led By Joshua Klatt, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received AIS surgery
Age range of 10-21
Must not have
Participants out of the age range 10-21
Other forms of scoliosis (not AIS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 6, post (ais) surgery
Awards & highlights

Summary

"This trial aims to see if giving a short course of steroids after surgery for Adolescent Idiopathic Scoliosis can help manage pain better and reduce the time spent in the hospital."

Who is the study for?
This trial is for young individuals aged 10-21 who have undergone surgery for Adolescent Idiopathic Scoliosis (AIS). It's not open to those outside this age range or those with other forms of scoliosis.
What is being tested?
The study is testing whether a short course of steroids, specifically Medrol dose packs, can help manage pain better and reduce the time patients stay in the hospital after AIS surgery compared to a placebo.
What are the potential side effects?
Potential side effects from Medrol may include increased appetite, mood changes, trouble sleeping, and higher blood pressure. Long-term use can lead to more serious side effects but this trial involves short-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 10 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not between the ages of 10 and 21.
Select...
My condition is a type of scoliosis that is not adolescent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 6, post (ais) surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 6, post (ais) surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analog Scale (VAS) pain

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Medrol tabletsExperimental Treatment1 Intervention
Encapsulated steroid Medrol tablets (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg)
Group II: Placebo tabletsPlacebo Group1 Intervention
Encapsulated placebo tablets per day (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medrol
2015
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,788,466 Total Patients Enrolled
24 Trials studying Pain
177,464 Patients Enrolled for Pain
Joshua Klatt, M.D.Principal InvestigatorUniversity of Utah Orthopaedics
~12 spots leftby Jan 2025
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