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Scoliosis; AdolescencePhase 3NCT04959591

Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

A Phase 3 study testing intravenous acetaminophen in people with Scoliosis; Adolescence, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 20 years
Conditions the study is for
Scoliosis; Adolescence
What is being tested?
intravenous acetaminophen
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteSouth Korea
Study dates
1 Jun 2021to 22 Apr 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: 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.

Read the 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
Being tested
intravenous acetaminophen, Placebo
Keywords
scoliosis, acetaminophen
Medical subject headings
Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravenous acetaminophenDrug

    experimental(pre): administration of IV acetaminophen

  • intravenous acetaminophenDrug

    experimental(post): administration of IV acetaminophen

  • PlaceboDrug

    placebo comparator: administration of normal saline

Study groups in NCT04959591
Study groupRoleWhat they receive
Experimental (Pre): AcetaminophenExperimentalParticipants 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.
Receives: Drug: intravenous acetaminophen
Experimental(post): AcetaminophenExperimentalParticipants 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.
Receives: Drug: intravenous acetaminophen
Placebo comparator : placeboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative analgesic consumption

    Comparison of total analgesic consumption between 3 groups in morphine equivalent

    Measured: 24 hours after surgery

Secondary outcomes (6)

  1. Postoperative analgesic consumption

    Comparison of total analgesic consumption between 3 groups in morphine equivalent

    Measured: 48 hours after surgery

  2. 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

    Measured: 4, 8, 24, 48 hours after surgery

  3. Frequency of side effects of opioids

    respiratory depression, postoperative nausea/vomiting, itching, constipation

    Measured: 24, 48, 72 hours after surgery

  4. Quality of recovery questionaire

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

    Measured: 3 to 5 days after surgery

  5. Postoperative recovery

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

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

  6. Length of hospital day

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2021
  2. Study start1 Jun 2021
  3. Primary completion15 Apr 2022
  4. Study completion22 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04959591
Sponsor's protocol ID
2021-0411
Status last verified
Dec 2022
First submitted
28 Jun 2021
Last updated
28 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 26035501

  • 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.

    PubMed 28564673

  • 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.

    PubMed 23299606

  • 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.

    PubMed 38383005

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing intravenous acetaminophen in people with Scoliosis; Adolescence, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative analgesic consumption (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04959591, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

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