Clinical trial NCT04959591: Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery
Official title: Use of Intravenous Acetaminophen in Adolescents and Pediatrics Undergoing Spinal Fusion Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scoliosis; Adolescence
Keywords: scoliosis, acetaminophen
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 99
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative analgesic consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative analgesic consumption
timeFrame: 48 hours after surgery
measure: Post operative pain scores
timeFrame: 4, 8, 24, 48 hours after surgery
measure: Frequency of side effects of opioids
timeFrame: 24, 48, 72 hours after surgery
measure: Quality of recovery questionaire
timeFrame: 3 to 5 days after surgery
measure: Postoperative recovery
timeFrame: from end of surgery to discharge from hospitalization (average 7 days)
measure: Length of hospital day
timeFrame: from end of surgery to discharge from hospitalization (average 7 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Won Uk Koh, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.