經鼻Butorphanol噴劑對於下腹腔鏡手術後疼痛控制之有效性及安全性評估

The Efficacy and Safety of Transnasal Butorphanol for Postoperative Pain Control Following Lower Laparoscopic Surgery

背景：本研究之目的在評估經鼻butorphanol噴劑，對於接受下腹部腹腔鏡手術之成年女性病人術後疼痛治療之有效性及安全性。方法：共有58位接受全身麻醉執行下腹部腹腔鏡手術之病患進入本研究。依隨機分為2組（每組28位病人），手術後，第一組接受經鼻butorphanol噴劑2毫克，第二組接受經鼻安慰劑噴劑。在治療後之6小時內，我們收集以下資料：視覺類比疼痛分類分數，病人使用自控系統嗎啡之需求次數及嗎啡消耗量，生命徵象，噁心，嘔吐及嗜睡。結果：經鼻butorphanol噴劑表現了較好的止痛效果：在用藥後30分鐘時減少了病人之視覺類比疼痛分數(P=0.043)；在用藥後30～60分鐘病人消耗了較少的自控式嗎啡量；在用藥後30～60分鐘(P= 0.001)及60～180分鐘(P= 0.031)，病人使用自控式嗎啡的需求次數減少。所有進入研究的病人之生命徵象皆很穩定，藥物所產生之副作用機率兩組間無顯著差異存在。結論：和安慰劑比較，經鼻butorphanol噴劑對於成年女性接受下腹部腹腔鏡手術所生之術後疼痛的止痛作用較佳，且所衍生之副作用很輕微。

Background: The aim of the study was to evaluate the efficacy and safety of transnasal butorphanol for postoperative analgesia in adult female patients undergoing lower laparoscopic surgery. Methods: Fifty-six women undergoing lower laparoscopic surgery under general anesthesia were enrolled in the study. They were randomly divided into 2 groups (n = 28 each). Postoperatively, group 1 received transnasal butorphanol 2 mg, whereas group 2 received transnasal placebo. During a 6-h post-treatment period, we collected the following data: scores of visual analogue pain scale, demand and delivery of patient-controlled analgesia (PCA) morphine, vital signs, nausea, vomiting, and somnolence. Results: Transnasal butorphanol clearly proved to have analgesic effect when compared with placebo as revealed by diminishment of visual analogue scale scores at 30 min (P = 0.043), less consumption of PCA morphine at 30-60 min (P = 0.002), and less demand of PCA morphine at 30-60 min (P = 0.001) and 60-180 min (P= 0.031). All patients displayed stable vital signs. The side effects between groups were not significantly different. Conclusions: In contrast with placebo transnasal butorphanol was effective in the treatment of postoperative pain in female patients undergoing lower laparoscopic surgery. It had minimum side effects.