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Completed

NCT Number: NCT06453083

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

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

Medrol

Drug

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

Other names: methylprednisolone

Primary outcomes

  1. Visual Analog Scale (VAS) pain

    Time frame: Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery

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

  2. Visual Analog Scale (VAS) pain

    Time frame: Day 2, post (AIS) surgery

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

  3. Visual Analog Scale (VAS) pain

    Time frame: Day 3, post (AIS) surgery

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

  4. Visual Analog Scale (VAS) pain

    Time frame: Day 4, post (AIS) surgery

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

  5. Visual Analog Scale (VAS) pain

    Time frame: Day 5, post (AIS) surgery

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

  6. Visual Analog Scale (VAS) pain

    Time frame: Day 6, post (AIS) surgery

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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