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Completed

NCT Number: NCT04959591

Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

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.

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Key information

Conditions

Scoliosis; Adolescence Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

11 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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;

  • The decrease in postoperative analgesic requirement following IV acetaminophen
  • The decrease in intensity of postoperative pain following IV acetaminophen
  • The quality of recovery including self-reported recovery, physical and functional recovery and length of stay
  • The preemptive analgesic effect of IV acetaminophen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous acetaminophen

Drug

experimental(pre): administration of IV acetaminophen

Placebo

Drug

placebo comparator: administration of normal saline

Primary outcomes

  1. Postoperative analgesic consumption

    Time frame: 24 hours after surgery

    Comparison of total analgesic consumption between 3 groups in morphine equivalent

Secondary outcomes

  1. Postoperative analgesic consumption

    Time frame: 48 hours after surgery

    Comparison of total analgesic consumption between 3 groups in morphine equivalent

  2. Post operative pain scores

    Time frame: 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

  3. Frequency of side effects of opioids

    Time frame: 24, 48, 72 hours after surgery

    respiratory depression, postoperative nausea/vomiting, itching, constipation

  4. Quality of recovery questionaire

    Time frame: 3 to 5 days after surgery

    self reported Quality of recovery-15 (QoR-15: 0, very poor recovery, 150, excellent recovery) questionnaire

  5. Postoperative recovery

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

    Timing of oral intake(hr), timing of ambulation(hr)

  6. Length of hospital day

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

    postoperative hospital stay(days), intensive care unit admission(days)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2021
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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