An Early Phase 1 interventional study of Placebo and Medrol in Pain, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by University of Utah · Early Phase 1, Interventional, and Treatment
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 57 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →University of Utah is the lead sponsor of 991 studies on the registry; 177 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.
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Exclusion Criteria:
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.)
Drug: Placebo
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)
Drug: Medrol
Placebo tablets will be dispensed to the participants for 6-days.
Medrol tablets will be dispensed to the participants for 6-days.
Also known as: methylprednisolone
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Time frame: Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Time frame: Day 2, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Time frame: Day 3, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Time frame: Day 4, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Time frame: Day 5, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Time frame: Day 6, post (AIS) surgery
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylprednisolone