MedPath

Medrol Dose Packs for Post-Operative Pain Control

Early Phase 1
Completed
Conditions
Pain
Interventions
Drug: Placebo
Registration Number
NCT06453083
Lead Sponsor
University of Utah
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
57
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo tabletsPlaceboEncapsulated 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.)
Medrol tabletsMedrolEncapsulated 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)
Primary Outcome Measures
NameTimeMethod
Visual Analog Scale (VAS) painDay 6, post (AIS) surgery

VAS pain score (0 no pain - 10 severe pain)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Utah Orthopaedic Center

🇺🇸

Salt Lake City, Utah, United States

© Copyright 2025. All Rights Reserved by MedPath