Nalbuphine Sebacate Combined with Parecoxib Was Effective in the Treatment of Post-surgical Pain: A Preliminary Observational Study

Nalbuphine Sebacate合併Parecoxib有效控制術後疼痛：臨床觀察研究之初步報告

背景：本研究之目的，在觀察一個新的長效注射型止痛藥物、同時也是鴉片類的促進－拮抗劑Nalbuphine Sebacate，在與Parecoxib合併使用於術後疼痛治療的臨床效果及安全性。方法：本研究收集了十位手術病患，於術後接受Nalbuphine Sebacate 150 mg作深部肌肉注射及Parecoxib40 mg作靜脈注射，並評估其藥物之止痛效果及安全性。我們使用言語數字評分法（VRS：0－10）評估其靜止及活動時之疼痛分數、並以Ramsay鎮靜分數（1－6）、疼痛對情緒影響分數（0－3）、睡眠品質分數（0－3）、止痛藥物引起之副作用及病患之滿意度（0－4）等作詳細評估及追蹤記錄。所有資料及數據收集於恢復室、病房及家中，並按該止痛藥注射後24、48、72小時及7天內作完整記錄。結果：結果顯示，病患的情緒及睡眠於注射Nalbuphine Sebacate後均沒有受疼痛影響，其鎮靜分數與麻醉恢復後並沒有明顯差異，但所有關於疼痛分數於麻醉恢復期與注射該藥後，於各評估階段結果的比較，均有明顯的改善（p＜0.05）。最常見的副作用為暈眩（50％）、噁心（20％）、嘔吐（10％）及嗜睡（10％）等，但大部份於2－3天內完全恢復。結論：Nalbuphine Sebacate合併Parecoxib使用，證實是有效治療術後疼痛。Nalbuphine Sebacate明顯的止痛效果為強效、作用時間長、但起始時間慢，並有限度的副作用。但其結果須更多研究個案來驗證。

Background: The aim of the study is to observe the clinical efficacy and safety of an agonist-antagonist opioid analgesic--nalbuphine sebacate, a new long-acting injectable pain killer, combined with parecoxib for post-surgical pain management. Methods: We collected 10 patients who underwent surgical procedures and received nalbuphine sebacate 150 mg via deep intramuscular and Parecoxib 40 mg via intravenous injection postoperatively. We evaluated its analgesic efficacy and safety using a verbal ranking pain scale ( 0-10 ) at rest and during movement, a sedation scale by Ramsay Sedation Score ( 1-6 ), scales for mood state induced by pain ( 0-3 ), quality of sleep ( 0-3 ), and satisfaction ( 0-4 ) and adverse effects. Data were collected in the post-anesthesia care unit, and in the general ward and at home 24, 48, 72 hours and 7 days after surgery. Results: There was no interference with mood and sleep after injection of nalbuphine sebacate , and also no significant differences in the sedation scale during the recovery period and following days after surgery. All data showed statistically significant improvement in the pain score after treatment compared with the post-anesthesia recovery period in the recovery room ( p<0.05 ). Adverse effects included dizziness (50%), nausea (20%), vomiting (10%), and somnolence (10%), most of which improved after 2 to 3 days. Conclusions: Nalbuphine sebacate combined with parecoxib was found to be effective in the treatment of post-surgical pain. Nalbuphine sebacate is an obviously potent analgesic, with a long duration of action, but with a slow onset of action and limited adverse effects. However, we need more cases to prove these results in the future.