Medrol Dose Packs for Post-Operative Pain Control

Utah System of Higher Education (USHE)

Status and phase: Completed; Early Phase 1

Conditions: Pain

Treatments: Drug: Placebo; Drug: Medrol

Study type: Interventional

Funder types: Other

Identifiers

NCT06453083

155546

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups, including a placebo group

Placebo tablets

Placebo Comparator group

Description:

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.)

Treatment:

Drug: Placebo

Medrol tablets

Experimental group

Description:

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)

Treatment:

Drug: Medrol