NCT04959591

Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

Use of Intravenous Acetaminophen in Adolescents and Pediatrics Undergoing Spinal Fusion Surgery: Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 11 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Scoliosis; Adolescence

Interventions

Type	Name	Description
DRUG	intravenous acetaminophen	experimental(pre): administration of IV acetaminophen
DRUG	intravenous acetaminophen	experimental(post): administration of IV acetaminophen
DRUG	Placebo	placebo comparator: administration of normal saline

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-04-15
• Completion: 2022-04-22
• First posted: 2021-07-13
• Last updated: 2022-12-28

Locations

1 site across 1 country: South Korea