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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo tablets | Placebo Comparator | 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.) |
|
| Medrol tablets | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablets will be dispensed to the participants for 6-days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery |
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | Day 2, post (AIS) surgery |
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | Day 3, post (AIS) surgery |
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | Day 4, post (AIS) surgery |
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | Day 5, post (AIS) surgery |
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | Day 6, post (AIS) surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Klatt, M.D. | University of Utah Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopaedic Center | Salt Lake City | Utah | 84108 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Medrol |
| Drug |
Medrol tablets will be dispensed to the participants for 6-days. |
|
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |