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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

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

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I am between 10 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not between the ages of 10 and 21.

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My condition is a type of scoliosis that is not adolescent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 6, post (ais) surgery

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

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

Primary study objectives

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

0 / 4Eligibility criteria met