There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.
Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
84
Children's Mercy Hospital
Kansas City, Missouri, United States
Number of Hours Until Tolerating Oral Intake
Defined as time when awakening after surgery until tolerating orals.
Time frame: Assessed daily in hospital while in hospital until taking orals, average 4 days.
Severity of Itching
Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome. Title of scale "Itching VAS". Scores were assessed daily for 5 days and an average of the five days was reported.
Time frame: Assessed daily while in hospital requiring PCA
Severity of Nausea
Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome. Name of scale "Nausea VAS". Scores were assessed daily for 5 days and an average of the five days reported.
Time frame: Assessed daily while in hospital requiring PCA.
Severity of Pain
Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum. Name of scale "Pain VAS". Scores were assessed daily for 5 days and an average of the five days was reported.
Time frame: Assessed by bedside nurse 3 times daily while requiring PCA
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