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NCT06453083 Clinical Trial

Medrol Dose Packs for Post-Operative Pain Control

Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06453083
Other study ID # 155546
Secondary ID
Status Enrolling by invitation
Phase Early Phase 1
First received
Last updated
Start date January 13, 2023
Est. completion date January 2025

Study information
Verified date June 2024
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years to 21 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo tablets will be dispensed to the participants for 6-days.
• Medrol
Medrol tablets will be dispensed to the participants for 6-days.

Locations
Country Name City State
United States University of Utah Orthopaedic Center Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

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