PrePex circumcision surveillance: Adverse events and analgesia for device removal
PrePex circumcision surveillance: Adverse events and analgesia for device removal
复制标题
DOI：
10.1371/journal.pone.0194271
复制
发表时间：
2018-03-26
期刊：
影响因子：
3.7
通讯作者：
Martinson, Neil
中科院分区：
文献类型：
--
作者：
Lebina, Limakatso;Milovanovic, Minja;Martinson, Neil
PrePex医用男性包皮环切术（MMC）器械相对容易放置和取出，只需经过一些培训。已在多个国家对PrePex进行了评价，以评估其可行性和可接受性。然而，几项研究报道了与remove. ObjectiveAssessment安全性PrePex和是否镇痛管理之前删除减少经历的pain by participants.MethodsA多站点非随机，前瞻性队列研究，其中成年（18-45岁）男性要求PrePex设备男性包皮环切术，从2014年7月至2015年3月在六个南非诊所入组。参与者在方案审查后开始监测后不久常规提供镇痛。镇痛方案的设备移除取决于药物的可用性在clinics.ResultsOf 1023登记参与者放置PrePex，98%（1004）的设备在研究诊所删除。他们的中位年龄为25岁（IQR：21-30）。HIV阳性率为3.6%（37/1023）。护士放置和取出了一半的器械。2.4%（25/1023）的参与者发生了不良事件; 15例需要手术干预：器械移位（5/14）、早期取出（3/14）、自行取出（5/14）和皮肤切除不足（2/14）。大多数（792：79%）参与者接受了镇痛。大多数接受对乙酰氨基酚可待因（33%），利多卡因（29%）或EMLA和口服组合（28%）。较低比例的参与者接受任何镇痛（利多卡因除外）前PrePex去除经历了严重的疼痛相比，那些谁没有接受镇痛（16.6%对29%：p = 0.0001）。取出前提供的止痛药可有效减少PrePex器械取出期间的重度疼痛。
BackgroundThe PrePex medical male circumcision (MMC) device is relatively easy to place and remove with some training. PrePex has been evaluated in several countries to assess feasibility and acceptability. However, several studies have reported pain associated with removal.ObjectiveTo assess safety of PrePex and whether analgesia administered prior to removal reduces pain experienced by participants.MethodsA multi-site non-randomized, prospective cohort study in which adult (18-45 years old) males requesting PrePex device male circumcision, were enrolled in six South African clinics from July 2014 to March 2015. Participants were routinely provided with analgesia shortly after the surveillance commenced following a protocol review. Analgesia regimen for device removal depended on medication availability at clinics.ResultsOf 1023 enrolled participants who had PrePex placed, 98% (1004) had the device removed at a study clinic. Their median age was 25 (IQR: 21-30) years. HIV sero-positivity was 3.6% (37/1023). Nurses placed and removed half of all devices. Adverse events were experienced by 2.4% (25/1023) of participants; 15 required surgical intervention: device displacement (5/14), early removals (3/14), self-removals (5/14) and insufficient skin removed (2/14). Majority (792: 79%) of participants received analgesia. Most received either paracetamol-codeine (33%), lidocaine (29%) or EMLA and Oral Combination (28%). A lower proportion of participants who received any analgesia (except for lidocaine) prior to PrePex removal experienced severe pain compared to those who received no analgesia (16.6% vs. 29%: p = 0.0001).ConclusionReported adverse events during this PrePex active surveillance were similar to previous reports and to those of surgical circumcision. Pain medication provided prior to removal is effective at decreasing severe pain during PrePex device removal.