The purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery.
Spinal fusion surgery to correct scoliosis causes severe postoperative pain in adolescents and pediatric patients. Thus, appropriate control of postoperative pain has a significant impact on postoperative recovery, patient satisfaction and reduction of hospital stay. Although pain control was achieved through only opioids, the importance of multimodal analgesia has recently been emphasized as opioid addiction and side effects increase. Acetaminophen is recommended as a key factor in multimodal analgesia and previous studies performed in adult spine surgery showed that intravenous administration of acetaminophen reduced the postoperative pain and opioid consumption. In addition, acetaminophen is a drug widely recognized for safety in adolescents and pediatric patients and has a fast and predictable analgesic effect. Therefore, the purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery. Thus the specific aim of this trial the investigators will determine is; 1. The decrease in postoperative analgesic requirement following IV acetaminophen 2. The decrease in intensity of postoperative pain following IV acetaminophen 3. The quality of recovery including self-reported recovery, physical and functional recovery and length of stay 4. The preemptive analgesic effect of IV acetaminophen
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
experimental(pre): administration of IV acetaminophen
experimental(post): administration of IV acetaminophen
placebo comparator: administration of normal saline
Asan Medical Center
Seoul, South Korea
Postoperative analgesic consumption
Comparison of total analgesic consumption between 3 groups in morphine equivalent
Time frame: 24 hours after surgery
Postoperative analgesic consumption
Comparison of total analgesic consumption between 3 groups in morphine equivalent
Time frame: 48 hours after surgery
Post operative pain scores
Comparison of NRS(numerical rating scale: 0, no pain, 10, worst possible pain) between 3 groups: Worst (cough) and mean pain scores
Time frame: 4, 8, 24, 48 hours after surgery
Frequency of side effects of opioids
respiratory depression, postoperative nausea/vomiting, itching, constipation
Time frame: 24, 48, 72 hours after surgery
Quality of recovery questionaire
self reported Quality of recovery-15 (QoR-15: 0, very poor recovery, 150, excellent recovery) questionnaire
Time frame: 3 to 5 days after surgery
Postoperative recovery
Timing of oral intake(hr), timing of ambulation(hr)
Time frame: from end of surgery to discharge from hospitalization (average 7 days)
Length of hospital day
postoperative hospital stay(days), intensive care unit admission(days)
Time frame: from end of surgery to discharge from hospitalization (average 7 days)
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