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Medrol Dose Packs for Post-Operative Pain Control

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06453083
Enrollment
57
Registered
2024-06-11
Start date
2023-01-13
Completion date
2024-12-17
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Adolescent Idiopathic Scoliosis (AIS), Steroid, Medrol, Placebo, Pain

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.

Interventions

DRUGPlacebo

Placebo tablets will be dispensed to the participants for 6-days.

DRUGMedrol

Medrol tablets will be dispensed to the participants for 6-days.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS) painDay 1, post Adolescent Idiopathic Scoliosis (AIS) surgeryVAS pain score (0 no pain - 10 severe pain)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026