A randomized trial of remifentanil for analgesia in external cephalic version for breech presentation

BACKGROUND: Although external cephalic version (ECV) can be effective for correcting the fetus in a cephalic presentation, it may be painful for the mother. This study aimed to evaluate the efficacy and safety of remifentanil for pain relief during ECV in China. METHODS: In all, 152 Chinese parturients with singleton breech presentation were randomly divided into 2 groups, each with 76 patients. All 152 patients were assigned to receive either remifentanil (infused at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg) or saline placebo. The study was performed between January 2012 and December 2015. Outcome measurements included the Numerical Rating Pain Scale score (0–10) after ECV, success rate for ECV, and maternal satisfaction after ECV. Adverse events were also evaluated. RESULTS: The study was completed by 146 patients. Remifentanil showed greater efficacy than placebo in decreasing the pain score immediately after ECV (remifentanil 4.6 ± 2.6 vs placebo 6.5 ± 2.7; P < 0.001). The success rate for ECV showed a significant difference between the 2 groups (remifentanil 56.5% vs placebo 39.5%; P = 0.04). Maternal satisfaction also showed a significant difference between the 2 groups (remifentanil 9.6 ± 1.4 vs placebo 6.4 ± 3.7; P < 0.001). However, the adverse events profiles were similar between both groups. CONCLUSION: The results of this study demonstrate that remifentanil is an effective intervention for reducing pain, achieving successful ECV, and increasing maternal satisfaction during ECV, and is generally well-tolerated without additional adverse effects.