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Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

NCT ID: NCT04959591

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-04-22

Brief Summary

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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

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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

Conditions

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Scoliosis; Adolescence

Keywords

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scoliosis, acetaminophen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

intravenous acetaminophen

Intervention Type DRUG

experimental(pre): administration of IV acetaminophen

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.

Group Type EXPERIMENTAL

intravenous acetaminophen

Intervention Type DRUG

experimental(post): administration of IV acetaminophen

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo comparator: administration of normal saline

Interventions

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intravenous acetaminophen

experimental(pre): administration of IV acetaminophen

Intervention Type DRUG

intravenous acetaminophen

experimental(post): administration of IV acetaminophen

Intervention Type DRUG

Placebo

placebo comparator: administration of normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Uk, Koh

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Uk Koh, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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

Reference Type BACKGROUND
PMID: 26035501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28564673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23299606 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38383005 (View on PubMed)

Other Identifiers

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2021-0411

Identifier Type: -

Identifier Source: org_study_id