AIM: Pulmonary vein isolation (PVI) is an established method for treatment of drug refractory atrial fibrillation. The aim of this study was to evaluate whether a more active regular supply of analgesic and sedative drugs reduces pain and discomfort. We also wanted to evaluate gender differences in pain perception and to compare standard radiofrequency (RF) with cryo balloon ablation (Cryo) from this perspective. METHODS: A total of 80 patients, 40 men, median age 58 (range 23-76) years, who underwent PVI under conscious sedation were studied. They were randomized to either standard treatment with morphine and diazepam (control group, C) or to a more active analgesic strategy (A) with pre-medication with oral midazolam mixture and intravenous alfentanil and midazolam regularly administrated during the procedure. Forty patients were treated with RF and 40 with Cryo. RESULTS: The majority of the patients experienced pain during the procedure. The maximal pain assessed with numerical rating scale (NRS), was lower in the active group compared with that in controls (p = 0.02). Women experienced more pain than men (p = 0.01). RF was more painful than Cryo (p < 0.001). CONCLUSION: An active regular supply of analgesic and sedative drugs reduce pain and discomfort during PVI. Women experience more pain than men during this procedure and PVI performed with Cryo is less painful than with RF.
RCT Entities:
AIM: Pulmonary vein isolation (PVI) is an established method for treatment of drug refractory atrial fibrillation. The aim of this study was to evaluate whether a more active regular supply of analgesic and sedative drugs reduces pain and discomfort. We also wanted to evaluate gender differences in pain perception and to compare standard radiofrequency (RF) with cryo balloon ablation (Cryo) from this perspective. METHODS: A total of 80 patients, 40 men, median age 58 (range 23-76) years, who underwent PVI under conscious sedation were studied. They were randomized to either standard treatment with morphine and diazepam (control group, C) or to a more active analgesic strategy (A) with pre-medication with oral midazolam mixture and intravenous alfentanil and midazolam regularly administrated during the procedure. Forty patients were treated with RF and 40 with Cryo. RESULTS: The majority of the patients experienced pain during the procedure. The maximal pain assessed with numerical rating scale (NRS), was lower in the active group compared with that in controls (p = 0.02). Women experienced more pain than men (p = 0.01). RF was more painful than Cryo (p < 0.001). CONCLUSION: An active regular supply of analgesic and sedative drugs reduce pain and discomfort during PVI. Women experience more pain than men during this procedure and PVI performed with Cryo is less painful than with RF.
Authors: Barry D Kussman; Christopher M Aasted; Meryem A Yücel; Sarah C Steele; Mark E Alexander; David A Boas; David Borsook; Lino Becerra Journal: PLoS One Date: 2016-07-14 Impact factor: 3.752