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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Adolescence
• Intervention / Treatment: Drug: intravenous acetaminophen; Drug: intravenous acetaminophen; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Won Uk Koh, M.D, Ph.D; Phone Number: 82-2-3010-5606; Email: koh9726@naver.com
• Study Contact Backup: Name: Yeon Ju Kim, M.D.; Phone Number: 82-2-3010-1785; Email: clever8808@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental (Pre): 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.	Drug: intravenous acetaminophen; experimental(pre): administration of IV acetaminophen; Drug: intravenous acetaminophen; experimental(post): administration of IV acetaminophen
Experimental: Experimental(post): 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.	Drug: intravenous acetaminophen; experimental(pre): administration of IV acetaminophen; Drug: intravenous acetaminophen; experimental(post): administration of IV acetaminophen
Placebo Comparator: Placebo comparator : 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.	Drug: Placebo; placebo comparator: administration of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesic consumption	Comparison of total analgesic consumption between 3 groups in morphine equivalent	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesic consumption	Comparison of total analgesic consumption between 3 groups in morphine equivalent	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	4, 8, 24, 48 hours after surgery
Frequency of side effects of opioids	respiratory depression, postoperative nausea/vomiting, itching, constipation	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	3 to 5 days after surgery
Postoperative recovery	Timing of oral intake(hr), timing of ambulation(hr)	from end of surgery to discharge from hospitalization (average 7 days)
Length of hospital day	postoperative hospital stay(days), intensive care unit admission(days)	from end of surgery to discharge from hospitalization (average 7 days)

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Won Uk Koh, M.D, Ph.D, Asan Medical Center

Publications and helpful links

General Publications

• Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
• Shastri N. Intravenous acetaminophen use in pediatrics. Pediatr Emerg Care. 2015 Jun;31(6):444-8; quiz 449-50. doi: 10.1097/PEC.0000000000000463.
• Ceelie I, de Wildt SN, van Dijk M, van den Berg MM, van den Bosch GE, Duivenvoorden HJ, de Leeuw TG, Mathot R, Knibbe CA, Tibboel D. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial. JAMA. 2013 Jan 9;309(2):149-54. doi: 10.1001/jama.2012.148050.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: scoliosis, acetaminophen
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2021-0411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No