BACKGROUND: The aim of the study was to determine whether premedication with oral diazepam (5-10 mg) before coronary angiography or percutaneous coronary intervention was associated with an increase in access site related complications. We also aimed to determine the effect on patient's perception of anxiety and pain. METHODS: A total of 760 consecutive patients scheduled to undergo either cardiac catheterization or percutaneous coronary intervention were randomized to either premedication with diazepam 5-10 mg 30 to 60 minutes prior to procedures (n = 379) or no premedication (n = 381). Administration of intravenous midazolam during the procedures was permitted and was at the operator's discretion. The primary end point of the study was a composite of hematoma (>or=3 cm), pseudoaneurysm (requiring surgical repair), arterial bleeding (requiring further compression), and vasovagal events. Secondary end points included the patient's perception of pain and anxiety (n = 144). RESULTS:Hematomas (17% vs 15%, P = .41), pseudoaneurysm (0.3% vs 0%, P = .31), arterial bleeding (3.4% vs 4.2%, P = .58), vasovagals (4% vs 3%, P = .32), and the combined primary end point (25% vs 22%, P = .145) were similar in the premedication and no premedication groups. There was also no difference in the number of patients experiencing periprocedural anxiety (36% vs 37%, P = .862). However, those premedicated with diazepam were significantly less likely to report periprocedural pain (32% vs 53%, P = .0114). CONCLUSIONS: Treatment with oral diazepam prior to cardiac catheterization and percutaneous coronary intervention does not alter rates of access site complications or anxiety, but does reduce periprocedural pain.
RCT Entities:
BACKGROUND: The aim of the study was to determine whether premedication with oral diazepam (5-10 mg) before coronary angiography or percutaneous coronary intervention was associated with an increase in access site related complications. We also aimed to determine the effect on patient's perception of anxiety and pain. METHODS: A total of 760 consecutive patients scheduled to undergo either cardiac catheterization or percutaneous coronary intervention were randomized to either premedication with diazepam 5-10 mg 30 to 60 minutes prior to procedures (n = 379) or no premedication (n = 381). Administration of intravenous midazolam during the procedures was permitted and was at the operator's discretion. The primary end point of the study was a composite of hematoma (>or=3 cm), pseudoaneurysm (requiring surgical repair), arterial bleeding (requiring further compression), and vasovagal events. Secondary end points included the patient's perception of pain and anxiety (n = 144). RESULTS:Hematomas (17% vs 15%, P = .41), pseudoaneurysm (0.3% vs 0%, P = .31), arterial bleeding (3.4% vs 4.2%, P = .58), vasovagals (4% vs 3%, P = .32), and the combined primary end point (25% vs 22%, P = .145) were similar in the premedication and no premedication groups. There was also no difference in the number of patients experiencing periprocedural anxiety (36% vs 37%, P = .862). However, those premedicated with diazepam were significantly less likely to report periprocedural pain (32% vs 53%, P = .0114). CONCLUSIONS: Treatment with oral diazepam prior to cardiac catheterization and percutaneous coronary intervention does not alter rates of access site complications or anxiety, but does reduce periprocedural pain.
Authors: Wieneke Vlastra; Ronak Delewi; Wim J Rohling; Tineke C Wagenaar; Alexander Hirsch; Martin G Meesterman; Marije M Vis; Joanna J Wykrzykowska; Karel T Koch; Robbert J de Winter; Jan Baan; Jan J Piek; Mirjam A G Sprangers; José P S Henriques Journal: Open Heart Date: 2018-09-23