Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.
Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.
Reprod Biomed Online. 2020 May;40(5):653-660. doi: 10.1016/j.rbmo.2020.01.021. Epub 2020 Jan 31.
Is fentanyl and midazolam non-inferior to pethidine and diazepam in pain relief during oocyte retrieval under conscious sedation?
A randomized double-blinded non-inferiority trial of 170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre. The women were randomized to receive intravenously either 0.1 mg fentanyl and 5 mg midazolam or 25 mg pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine. The primary outcome was abdominal pain level during retrieval assessed by linear visual analogue scale from 0-10. Secondary outcomes included vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates. A pre-defined non-inferiority margin of 1 for the difference in pain levels between two groups was set.
Vaginal and abdominal pain levels during retrieval were significantly lower in the fentanyl and midazolam group compared with the pethidine and diazepam group (per-protocol analysis, vaginal pain: 1.6 versus 4.3; mean difference: -2.7, 95% CI -3.7, -1.8; P < 0.001; abdominal pain: 2.9 versus 5.2; mean difference: -2.3, 95% CI -3.3 to -1.3; P < 0.001 for non-inferiority). No differences were observed in these pain levels after retrieval. Most women experienced no postoperative side-effects. The fentanyl and midazolam group had better sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure than the pethidine and diazepam group. No significant differences were found in clinical pregnancy and ongoing pregnancy rates between the two groups.
The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.
在接受镇静下取卵过程中，芬太尼和咪达唑仑与哌替啶和地西泮相比，在缓解疼痛方面是否无差异？
一项在辅助生殖中心进行的 170 例接受镇静下取卵的不孕妇女的随机双盲非劣效性试验。这些妇女被随机静脉注射 0.1 毫克芬太尼和 5 毫克咪达唑仑或 25 毫克哌替啶和 5 毫克地西泮，同时行宫颈旁阻滞，给予 10 毫升 1%利多卡因。主要结局是通过 0-10 的线性视觉模拟评分评估取卵过程中的腹部疼痛程度。次要结局包括取卵过程中和取卵后阴道疼痛程度以及术后腹部疼痛程度和副作用、满意度、临床妊娠率和持续妊娠率。设定两组之间疼痛水平差异的非劣效性边界为 1。
芬太尼和咪达唑仑组的阴道和腹部疼痛程度在取卵过程中明显低于哌替啶和地西泮组（按方案分析，阴道疼痛：1.6 对 4.3；平均差异：-2.7，95%CI-3.7，-1.8；P<0.001；腹部疼痛：2.9 对 5.2；平均差异：-2.3，95%CI-3.3 至-1.3；P<0.001 表示非劣效性）。在取卵后，这些疼痛水平没有差异。大多数妇女没有术后副作用。芬太尼和咪达唑仑组在镇静水平、对疼痛缓解的满意度以及对整个取卵过程的满意度方面均优于哌替啶和地西泮组。两组的临床妊娠率和持续妊娠率无显著差异。
芬太尼和咪达唑仑组在取卵过程中的阴道和腹部疼痛程度明显低于哌替啶和地西泮组。
