Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

Phase 3

Completed

Brief 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

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

patients who refuse to participate in this study
patients unable to communicate due to mental impairment or developmental delay
patients allergic to acetaminophen or its additives or who are contraindicated in acetaminophen administration for other reasons
patients with existing liver diseases or dysfunction (i.e. active hepatitis, clinically relevant chronic liver conditions, elevated liver enzymes)
patients who are judged ineligible by the medical staff to participate in the study for other reasons

Arm && Interventions

Group	Intervention	Description
Placebo comparator : placebo	Placebo	Participants will receive 1.5ml/kg placebo (0.9% saline) before and after surgery and the same dose will be given postoperatively at 8hour intervals for 24hours.
Experimental(post): Acetaminophen	intravenous acetaminophen	Participants will receive 15mg/kg intravenous acetaminophen 15mg/kg at the end of surgery before skin closure and the same dose will be given postoperatively at 8 hour intervals for 24hours. A single dose of placebo (saline) will also be given after anesthetic induction/before surgical incision.
Experimental (Pre): Acetaminophen	intravenous acetaminophen	Participants will receive 15mg/kg intravenous acetaminophen 15mg/kg after anesthetic induction/before surgical incision and the same dose will be given postoperatively at 8 hour intervals for 24hours. A single dose of placebo (saline) will also be given at the end of surgery before skin closure.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesic consumption	24 hours after surgery	Comparison of total analgesic consumption between 3 groups in morphine equivalent

Secondary Outcome Measures

Name	Time	Method
Frequency of side effects of opioids	24, 48, 72 hours after surgery	respiratory depression, postoperative nausea/vomiting, itching, constipation
Post operative pain scores	4, 8, 24, 48 hours after surgery	Comparison of NRS(numerical rating scale: 0, no pain, 10, worst possible pain) between 3 groups: Worst (cough) and mean pain scores
Postoperative recovery	from end of surgery to discharge from hospitalization (average 7 days)	Timing of oral intake(hr), timing of ambulation(hr)
Postoperative analgesic consumption	48 hours after surgery	Comparison of total analgesic consumption between 3 groups in morphine equivalent
Length of hospital day	from end of surgery to discharge from hospitalization (average 7 days)	postoperative hospital stay(days), intensive care unit admission(days)
Quality of recovery questionaire	3 to 5 days after surgery	self reported Quality of recovery-15 (QoR-15: 0, very poor recovery, 150, excellent recovery) questionnaire