Clinical trial

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

ID

Name

155546

Description

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.

Trial arms

Trial start

2023-01-13

Estimated PCD

2025-01-01

Trial end

2025-01-01

Phase

Early phase I

Treatment

Placebo

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

Arms:

Placebo tablets

Medrol

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

Arms:

Medrol tablets

Other names:

methylprednisolone

Size

90

Primary endpoint

Visual Analog Scale (VAS) pain

Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery

Visual Analog Scale (VAS) pain

Day 2, post (AIS) surgery

Visual Analog Scale (VAS) pain

Day 3, post (AIS) surgery

Visual Analog Scale (VAS) pain

Day 4, post (AIS) surgery

Visual Analog Scale (VAS) pain

Day 5, post (AIS) surgery

Visual Analog Scale (VAS) pain

Day 6, post (AIS) surgery

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-06-11

1 organization

1 product

1 drug

1 indication

Organization

University of Utah

Drug

Indication

Product