Medrol Dose Packs for Post-Operative Pain Control

January 5, 2025 updated by: Joshua Klatt, University of Utah

Prospective Randomized Trial Using Medrol Dose Packs for Post-Operative Pain Control

The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Post-operative pain control following AIS surgery is challenging. Sub-optimal pain management results in emotional distress and prolonged hospital length of stay. Previous studies have shown that a short course of steroids following spine surgery is safe and improves pain control. To better understand the effects of the addition of steroids to a routine pain management strategy, a randomized prospective study with and without steroids will determine the benefit, if any, to the addition of steroids to the investigators already used pain protocol.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age range of 10-21
  • received AIS surgery

Exclusion Criteria:

  • participants out of the age range 10-21
  • other forms of scoliosis (not AIS)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo tablets
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.)
Drug: Placebo
Placebo tablets will be dispensed to the participants for 6-days.
Experimental: Medrol tablets
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)
Drug: Medrol
Medrol tablets will be dispensed to the participants for 6-days.
Other Names:
  • methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) pain
Time Frame: Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery
Visual Analog Scale (VAS) pain
Time Frame: Day 2, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Day 2, post (AIS) surgery
Visual Analog Scale (VAS) pain
Time Frame: Day 3, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Day 3, post (AIS) surgery
Visual Analog Scale (VAS) pain
Time Frame: Day 4, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Day 4, post (AIS) surgery
Visual Analog Scale (VAS) pain
Time Frame: Day 5, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Day 5, post (AIS) surgery
Visual Analog Scale (VAS) pain
Time Frame: Day 6, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Day 6, post (AIS) surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Joshua Klatt, M.D., University of Utah Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2023

Primary Completion (Actual)

December 17, 2024

Study Completion (Actual)

December 17, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 155546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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