Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

NCT04959591 | Completed Phase 3

• 1 other identifier: 2021-0411
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescence

Keywords

scoliosis, acetaminophen

Outcome Measures

Primary Outcomes (1)

• Postoperative analgesic consumption

  Comparison of total analgesic consumption between 3 groups in morphine equivalent

  24 hours after surgery

Secondary Outcomes (6)

• Postoperative analgesic consumption

  48 hours after surgery

• Post operative pain scores

  4, 8, 24, 48 hours after surgery

• Frequency of side effects of opioids

  24, 48, 72 hours after surgery

• Quality of recovery questionaire

  3 to 5 days after surgery

• Postoperative recovery

  from end of surgery to discharge from hospitalization (average 7 days)

Study Arms (3)

Experimental (Pre): Acetaminophen

EXPERIMENTAL

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(post): Acetaminophen

EXPERIMENTAL

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

Placebo comparator : placebo

PLACEBO COMPARATOR

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

Interventions

intravenous acetaminophen DRUG

experimental(pre): administration of IV acetaminophen

Experimental (Pre): Acetaminophen

Placebo DRUG

placebo comparator: administration of normal saline

Placebo comparator : placebo

Eligibility Criteria

• Age: 11 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (4)

• Shastri N. Intravenous acetaminophen use in pediatrics. Pediatr Emerg Care. 2015 Jun;31(6):444-8; quiz 449-50. doi: 10.1097/PEC.0000000000000463.

  PMID: 26035501 BACKGROUND

• 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.

  PMID: 28564673 BACKGROUND

• 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.

  PMID: 23299606 BACKGROUND

• Kim YJ, Kim HJ, Kim S, Kim H, Lee CS, Hwang CJ, Cho JH, Ro YJ, Koh WU. Comparison of preemptive and preventive intravenous acetaminophen on opioid consumption in pediatrics undergoing posterior spinal fusion surgery: a randomized controlled trial. Korean J Anesthesiol. 2024 Jun;77(3):326-334. doi: 10.4097/kja.23747. Epub 2024 Feb 20.

  PMID: 38383005 DERIVED

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Won Uk Koh, M.D, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The designated research pharmacist will prepare the both study drug (IV acetaminophen) and placebo and will dispense the study drug according to treatment allocation. Treatment allocation will remain concealed from all other investigators involved in the conduct and analysis of the trial. All other medical staff involved in patient care during the hospital stay of study participant and the study participants itself along with guardians will be also blinded throughout.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 13, 2021
• Study Start: June 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 22, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)