Medrol Dose Packs for Post-Operative Pain Control

NCT ID: NCT06453083

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2024-12-17

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Medrol

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Medrol

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

Intervention Type DRUG

Other Intervention Names

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methylprednisolone

Eligibility Criteria

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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)
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Joshua Klatt

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua Klatt, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopaedics

Locations

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University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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155546

Identifier Type: -

Identifier Source: org_study_id

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