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Introduction <p>Acute postoperative pain following open reduction and internal fixation of mandibular fractures poses a clinical challenge. Diclofenac sodium, a COX-inhibitor, remains the standard first-line analgesic in many perioperative settings, however, renal insufficiency, peptic ulceration, and bleeding diathesis frequently restrict its use in polytrauma patients. Ascorbic acid has demonstrated antinociceptive properties through neuropeptide amidation, catecholamine biosynthesis, and neuromodulation, yet its analgesic role in maxillofacial trauma has not been previously examined in a randomised trial.</p> Materials and Methods <p>A single-centre pilot randomised controlled trial enrolled 24 adults with confirmed mandibular fractures scheduled for open reduction and internal fixation under general anaesthesia. Participants were allocated equally to intravenous diclofenac sodium 75&#xa0;mg (Group A) or intravenous ascorbic acid 3000&#xa0;mg (Group B), administered at wound closure. Pain was assessed using the FLACC scale by a blinded evaluator. Analysis included paired and independent samples t-tests, 95% confidence intervals, and Cohen’s d effect sizes.</p> Results <p>Within first two post operative hours, Group A demonstrated a mean postoperative pain score reduction of 4.25 points (7.83 to 3.58; <i>p</i> &lt; 0.001; Cohen’s d = 6.84). Group B showed a reduction of 1.42 points (7.83 to 6.42; <i>p</i> &lt; 0.001; Cohen’s d = 2.75). The between-group difference was 2.67 points, significantly favouring diclofenac (<i>p</i> &lt; 0.001; Cohen’s d = 3.45). No adverse events or rescue analgesia were recorded in either group.</p> Conclusion <p>Diclofenac sodium provided markedly superior analgesia and remains the appropriate first-line agent. These findings are limited to the immediate postoperative period (up to two hours post-operatively). Vitamin C produced a statistically significant but clinically modest pain reduction within this window, with an excellent safety profile, supporting a possible adjunctive role in multimodal protocols, particularly where NSAIDs are contraindicated, but not as a replacement analgesic. Larger, adequately powered multicentre trials are warranted.</p>

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Comparative Evaluation of Intravenous Vitamin C and Diclofenac Sodium for Postoperative Pain Control in Mandibular Fractures: A Pilot Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2026年7月6日

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  • Digvijay Shitole,
  • Sonal B. Shah,
  • Preeti Athwani

摘要

Introduction

Acute postoperative pain following open reduction and internal fixation of mandibular fractures poses a clinical challenge. Diclofenac sodium, a COX-inhibitor, remains the standard first-line analgesic in many perioperative settings, however, renal insufficiency, peptic ulceration, and bleeding diathesis frequently restrict its use in polytrauma patients. Ascorbic acid has demonstrated antinociceptive properties through neuropeptide amidation, catecholamine biosynthesis, and neuromodulation, yet its analgesic role in maxillofacial trauma has not been previously examined in a randomised trial.

Materials and Methods

A single-centre pilot randomised controlled trial enrolled 24 adults with confirmed mandibular fractures scheduled for open reduction and internal fixation under general anaesthesia. Participants were allocated equally to intravenous diclofenac sodium 75 mg (Group A) or intravenous ascorbic acid 3000 mg (Group B), administered at wound closure. Pain was assessed using the FLACC scale by a blinded evaluator. Analysis included paired and independent samples t-tests, 95% confidence intervals, and Cohen’s d effect sizes.

Results

Within first two post operative hours, Group A demonstrated a mean postoperative pain score reduction of 4.25 points (7.83 to 3.58; p < 0.001; Cohen’s d = 6.84). Group B showed a reduction of 1.42 points (7.83 to 6.42; p < 0.001; Cohen’s d = 2.75). The between-group difference was 2.67 points, significantly favouring diclofenac (p < 0.001; Cohen’s d = 3.45). No adverse events or rescue analgesia were recorded in either group.

Conclusion

Diclofenac sodium provided markedly superior analgesia and remains the appropriate first-line agent. These findings are limited to the immediate postoperative period (up to two hours post-operatively). Vitamin C produced a statistically significant but clinically modest pain reduction within this window, with an excellent safety profile, supporting a possible adjunctive role in multimodal protocols, particularly where NSAIDs are contraindicated, but not as a replacement analgesic. Larger, adequately powered multicentre trials are warranted.