BACKGROUND: There is no consensus with respect to the use of analgesia during femoral arterial sheath removal after percutaneous coronary intervention (PCI). We performed a randomized controlled trial to assess the impact of intravenous sedation and local anesthesia during femoral sheath removal after PCI on patient comfort and the incidence of vasovagal reactions. METHODS:All patients undergoing PCI whose femoral sheaths were to be removed with assisted manual compression were eligible. Patients were randomized to receive either intravenous sedation (Fentanyl and Midazolam) or local anesthesia (1% lignocaine) infiltrated around the sheath site or both or neither. The primary endpoint of the study was the patients reported worst pain according to a Visual Analogue scale (VAS) after sheath removal. The incidence and predictors of vasovagal reactions during sheath removal and occurrence of vascular complications was also determined. RESULTS: A total of 611 patients were randomized into this study. The mean pain score was highest in the local anesthesia only arm as compared to the sedation only arm, the combined local and sedation arm and the neither sedation or local arm (p=0.001). vasovagal reactions were experienced by 35 patients (5.1%) with the highest percentage in the local anesthesia only group (9.8%). Multivariate logistic regression analysis identified a higher pain score (OR 1.18, 95% CI 1.12-1.24, p=0.001), use of glyceryl trinitrate during sheath removal (OR 9.05, 95% CI 5.06-16.1, p<0.001), a lower body mass index (OR 1.12, 95% CI 1.08-1.18, p=0.009) and the left anterior descending artery as the treated vessel (OR 5.2, 95% CI 3.41-7.87, p<0.001) as independent predictors of the occurrence of a vasovagal reaction. There was no significant difference in vascular complications between the 4 study groups. CONCLUSIONS: The routine use of fentanyl and midazolam prior to sheath removal leads to a reduction in pain perception and vasovagal incidence, whilst the routine use of local infiltration during sheath removal should be discouraged as it leads to more pain and a trend to more vasovagal reactions.
RCT Entities:
BACKGROUND: There is no consensus with respect to the use of analgesia during femoral arterial sheath removal after percutaneous coronary intervention (PCI). We performed a randomized controlled trial to assess the impact of intravenous sedation and local anesthesia during femoral sheath removal after PCI on patient comfort and the incidence of vasovagal reactions. METHODS: All patients undergoing PCI whose femoral sheaths were to be removed with assisted manual compression were eligible. Patients were randomized to receive either intravenous sedation (Fentanyl and Midazolam) or local anesthesia (1% lignocaine) infiltrated around the sheath site or both or neither. The primary endpoint of the study was the patients reported worst pain according to a Visual Analogue scale (VAS) after sheath removal. The incidence and predictors of vasovagal reactions during sheath removal and occurrence of vascular complications was also determined. RESULTS: A total of 611 patients were randomized into this study. The mean pain score was highest in the local anesthesia only arm as compared to the sedation only arm, the combined local and sedation arm and the neither sedation or local arm (p=0.001). vasovagal reactions were experienced by 35 patients (5.1%) with the highest percentage in the local anesthesia only group (9.8%). Multivariate logistic regression analysis identified a higher pain score (OR 1.18, 95% CI 1.12-1.24, p=0.001), use of glyceryl trinitrate during sheath removal (OR 9.05, 95% CI 5.06-16.1, p<0.001), a lower body mass index (OR 1.12, 95% CI 1.08-1.18, p=0.009) and the left anterior descending artery as the treated vessel (OR 5.2, 95% CI 3.41-7.87, p<0.001) as independent predictors of the occurrence of a vasovagal reaction. There was no significant difference in vascular complications between the 4 study groups. CONCLUSIONS: The routine use of fentanyl and midazolam prior to sheath removal leads to a reduction in pain perception and vasovagal incidence, whilst the routine use of local infiltration during sheath removal should be discouraged as it leads to more pain and a trend to more vasovagal reactions.