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Effect of Intravenous Acetaminophen on Preemptive Multimodal Analgesia for Pediatric Osteotomy Correction Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

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. Keywords: acetaminophen, multimodal analgesia, opioid-sparing analgesia, osteotomy correction surgery, pediatric analgesia, randomized controlled trial

Source: Drug Design Development and Therapy

DOI: 10.2147/dddt.s655651

Authors: Lei Wang, Lei Wu, Yi Zhu, Zhen Du, Ting Xiao, Shuangquan Qu

Institutions: Central South University, Hunan Children's Hospital

Language: English

Topic: Anesthesia and Pain Management

Subfield: Anesthesiology and Pain Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,836