Effect of Intravenous Acetaminophen on Preemptive Multimodal Analgesia for Pediatric Osteotomy Correction Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial
- 1Department of Anesthesiology, The Affiliated Children’s Hospital of Xiangya School of Medicine, Central South University (Hunan Children’s Hospital), Changsha, Hunan, People’s Republic of China
Abstract
Purpose: Children undergoing Osteotomy correction surgery can experience substantial postoperative pain and frequently require opioids. We evaluated whether a single preincision dose of intravenous acetaminophen, added to a standardized multimodal analgesic regimen, reduces postoperative pain and perioperative opioid requirements.
Patients and Methods: In this prospective, randomized, double-blind, placebo-controlled trial, 96 children aged 6–18 years undergoing elective lower-limb osteotomy correction surgery were randomized 1:1 to intravenous acetaminophen 15 mg/kg or volume-matched 0.9% sodium chloride administered 30 minutes before skin incision. The primary outcome was the incidence of moderate-to-severe pain within 72 hours after surgery, defined as a Face, Legs, Activity, Cry, Consolability (FLACC) score ≥4 at any scheduled assessment. The primary analysis used the modified intention-to-treat (mITT) population (n=95; 48 acetaminophen, 47 placebo). Secondary outcomes included perioperative opioid consumption, pain intensity, rescue analgesia, patient-controlled intravenous analgesia use, subjective sleep quality, and adverse events. The trial was prospectively registered (ChiCTR2500095363; January 6, 2025).
Results: Moderate-to-severe pain occurred in 8/48 (16.7%) versus 21/47 (44.7%) children, an absolute risk reduction of 28.0% (RR, 0.37; 95% CI, 0.2–0.8; P=0.004). Intraoperative remifentanil consumption was lower in the acetaminophen group (median, 0.8 vs 1.3 mg; between-group difference, 0.6 mg; 95% CI, 0.3–0.9; P<0.001). Postoperative 72-hour morphine-equivalent consumption was also lower (median, 90.0 vs 105.0 mg; difference, 14.4 mg; 95% CI, 2.7–26.5; P=0.018). Longitudinal ordinal GEE demonstrated significant group-by-time interactions for FLACC scores both at rest (P<0.001) and during movement (P=0.002), with the analgesic benefit concentrated in the early postoperative period. Subjective sleep NRS scores were lower in the acetaminophen group on POD1 (Holm-adjusted P=0.005), although the overall group-by-time interaction was not significant (P=0.411). No increase in perioperative adverse events was observed in the acetaminophen group.
Conclusion: Preincision intravenous acetaminophen was associated with a lower incidence of moderate-to-severe postoperative pain and reduced opioid requirements in children undergoing osteotomy correction surgery. Larger multicenter trials are warranted to confirm these findings.
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BibTeX
@article{wang2026effect,
title = {{Effect of Intravenous Acetaminophen on Preemptive Multimodal Analgesia for Pediatric Osteotomy Correction Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial}},
author = {Lei Wang and Lei Wu and Yi Zhu and Zhen Du and Ting Xiao and Shuangquan Qu},
journal = {Drug Design, Development and Therapy},
year = {2026},
month = oct,
doi = {10.2147/dddt.s655651},
url = {https://doi.org/10.2147/dddt.s655651},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Effect of Intravenous Acetaminophen on Preemptive Multimodal Analgesia for Pediatric Osteotomy Correction Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial
AU - Lei Wang
AU - Lei Wu
AU - Yi Zhu
AU - Zhen Du
AU - Ting Xiao
AU - Shuangquan Qu
PY - 2026
DA - 2026/10/30
JO - Drug Design, Development and Therapy
DO - 10.2147/dddt.s655651
UR - https://doi.org/10.2147/dddt.s655651
AB - Purpose: Children undergoing Osteotomy correction surgery can experience substantial postoperative pain and frequently require opioids. We evaluated whether a single preincision dose of intravenous acetaminophen, added to a standardized multimodal analgesic regimen, reduces postoperative pain and perioperative opioid requirements. Patients and Methods: In this prospective, randomized, double-blind, placebo-controlled trial, 96 children aged 6–18 years undergoing elective lower-limb osteotomy correction surgery were randomized 1:1 to intravenous acetaminophen 15 mg/kg or volume-matched 0.9% sodium chloride administered 30 minutes before skin incision. The primary outcome was the incidence of moderate-to-severe pain within 72 hours after surgery, defined as a Face, Legs, Activity, Cry, Consolability (FLACC) score ≥4 at any scheduled assessment. The primary analysis used the modified intention-to-treat (mITT) population (n=95; 48 acetaminophen, 47 placebo). Secondary outcomes included perioperative opioid consumption, pain intensity, rescue analgesia, patient-controlled intravenous analgesia use, subjective sleep quality, and adverse events. The trial was prospectively registered (ChiCTR2500095363; January 6, 2025). Results: Moderate-to-severe pain occurred in 8/48 (16.7%) versus 21/47 (44.7%) children, an absolute risk reduction of 28.0% (RR, 0.37; 95% CI, 0.2–0.8; P=0.004). Intraoperative remifentanil consumption was lower in the acetaminophen group (median, 0.8 vs 1.3 mg; between-group difference, 0.6 mg; 95% CI, 0.3–0.9; P<0.001). Postoperative 72-hour morphine-equivalent consumption was also lower (median, 90.0 vs 105.0 mg; difference, 14.4 mg; 95% CI, 2.7–26.5; P=0.018). Longitudinal ordinal GEE demonstrated significant group-by-time interactions for FLACC scores both at rest (P<0.001) and during movement (P=0.002), with the analgesic benefit concentrated in the early postoperative period. Subjective sleep NRS scores were lower in the acetaminophen group on POD1 (Holm-adjusted P=0.005), although the overall group-by-time interaction was not significant (P=0.411). No increase in perioperative adverse events was observed in the acetaminophen group. Conclusion: Preincision intravenous acetaminophen was associated with a lower incidence of moderate-to-severe postoperative pain and reduced opioid requirements in children undergoing osteotomy correction surgery. Larger multicenter trials are warranted to confirm these findings.
SN - 1177-8881
ER -