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<p>Postoperative pain management is essential for enhancing recovery and patient satisfaction. This randomized controlled trial, aimed to evaluate the effectiveness and safety of trans-nasal Tapentadol compared to intravenous Tramadol and Diclofenac in postoperative pain relief, was conducted at Rajendra Institute of Medical Sciences, Ranchi, between September 2021 and March 2024. A total of 193 adult patients undergoing major surgery were randomized into three groups: trans-nasal Tapentadol (22.5&#xa0;mg spray 12-hourly), intravenous Tramadol (100&#xa0;mg IV 8-hourly), or intravenous Diclofenac (50&#xa0;mg IV 12-hourly). Pain intensity was measured using the visual analog scale (VAS) over three postoperative days. Secondary outcomes included the need for adjuvant analgesia, adverse effects, and patient preference for analgesic mode. The mean pain scores on the first, second, and third days postoperatively were 2.67 ± 0.83, 1.66 ± 0.78, and 1.17 ± 0.69, respectively, with no significant differences among the three groups. The use of adjuvant analgesics and incidence of adverse effects did not differ significantly among groups (<i>p</i> &gt; 0.05). However, the incidence of adverse effects was significantly lower in the trans-nasal Tapentadol group (<i>p</i> = 0.016). Only one patient in the Tapentadol group reported nasal stiffness, while gastrointestinal side effects were more common in the Tramadol and Diclofenac groups. Most patients (97.98%) preferred the nasal spray route.&#xa0;We concluded that trans-nasal&#xa0;Tapentadol is as effective as intravenous Tramadol and Diclofenac for postoperative pain relief, with fewer adverse effects and higher patient preference. It offers a promising, non-invasive alternative for postoperative pain management, especially in daycare surgeries. Further research is needed to confirm these findings in larger populations and extended follow-up periods. Registered with the Central Trial Registry of India (CTRI), Regd. No. CTRI/2021/09/036432. URL:<a href="https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTEwOTQ=&amp;Enc=&amp;userName=tapentadol">https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTEwOTQ=&amp;Enc=&amp;userName=tapentadol</a>.</p>

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Randomized Controlled Trial of Trans-Nasal Tapentadol Vs. Intravenous Tramadol and Diclofenac for Postoperative Pain Management

  • 期刊论文

  • 发表日期：

    2025年3月10日

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  • Nishith M. Paul Ekka,
  • Archana Dipa Sangita Kujur,
  • Dipendra Kumar Sinha,
  • Binay Kumar,
  • Jiwesh Kumar,
  • Sourabh Kumar

摘要

Postoperative pain management is essential for enhancing recovery and patient satisfaction. This randomized controlled trial, aimed to evaluate the effectiveness and safety of trans-nasal Tapentadol compared to intravenous Tramadol and Diclofenac in postoperative pain relief, was conducted at Rajendra Institute of Medical Sciences, Ranchi, between September 2021 and March 2024. A total of 193 adult patients undergoing major surgery were randomized into three groups: trans-nasal Tapentadol (22.5 mg spray 12-hourly), intravenous Tramadol (100 mg IV 8-hourly), or intravenous Diclofenac (50 mg IV 12-hourly). Pain intensity was measured using the visual analog scale (VAS) over three postoperative days. Secondary outcomes included the need for adjuvant analgesia, adverse effects, and patient preference for analgesic mode. The mean pain scores on the first, second, and third days postoperatively were 2.67 ± 0.83, 1.66 ± 0.78, and 1.17 ± 0.69, respectively, with no significant differences among the three groups. The use of adjuvant analgesics and incidence of adverse effects did not differ significantly among groups (p > 0.05). However, the incidence of adverse effects was significantly lower in the trans-nasal Tapentadol group (p = 0.016). Only one patient in the Tapentadol group reported nasal stiffness, while gastrointestinal side effects were more common in the Tramadol and Diclofenac groups. Most patients (97.98%) preferred the nasal spray route. We concluded that trans-nasal Tapentadol is as effective as intravenous Tramadol and Diclofenac for postoperative pain relief, with fewer adverse effects and higher patient preference. It offers a promising, non-invasive alternative for postoperative pain management, especially in daycare surgeries. Further research is needed to confirm these findings in larger populations and extended follow-up periods. Registered with the Central Trial Registry of India (CTRI), Regd. No. CTRI/2021/09/036432. URL:https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTEwOTQ=&Enc=&userName=tapentadol.