Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Scoliosis; Adolescence

Treatments: Drug: Placebo; Drug: intravenous acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04959591

2021-0411

Details and patient eligibility

About

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.

Full 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

Enrollment: 99 patients

Sex: All

Ages: 11 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status 1-3
• patients undergoing spinal fusion surgery

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

Experimental (Pre): Acetaminophen

Experimental group

Description:

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.

Treatment:

Drug: intravenous acetaminophen

Drug: intravenous acetaminophen

Experimental(post): Acetaminophen

Experimental group

Description:

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.

Treatment:

Drug: intravenous acetaminophen

Drug: intravenous acetaminophen

Placebo comparator : placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo