Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

Scoliosis; Adolescence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959591
• Other study ID #: 2021-0411
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: April 22, 2022

Study information

• Verified date: December 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 22, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis; Adolescence

Intervention

Drug:
• intravenous acetaminophen
experimental(pre): administration of IV acetaminophen
• intravenous acetaminophen
experimental(post): administration of IV acetaminophen
• Placebo
placebo comparator: administration of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesic consumption	Comparison of total analgesic consumption between 3 groups in morphine equivalent	24 hours after surgery
Secondary	Postoperative analgesic consumption	Comparison of total analgesic consumption between 3 groups in morphine equivalent	48 hours after surgery
Secondary	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
Secondary	Frequency of side effects of opioids	respiratory depression, postoperative nausea/vomiting, itching, constipation	24, 48, 72 hours after surgery
Secondary	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
Secondary	Postoperative recovery	Timing of oral intake(hr), timing of ambulation(hr)	from end of surgery to discharge from hospitalization (average 7 days)
Secondary	Length of hospital day	postoperative hospital stay(days), intensive care unit admission(days)	from end of surgery to discharge from hospitalization (average 7 days)