Moreover, subgroup analysis and comparison of first vs second venipuncture pain intensities were also performed as secondary outcomes. The secondary outcomes were VRS score for venipuncture pain and the frequency of adverse effects, including cutaneous symptoms and local anesthetic toxicity. The primary outcome was the VAS score for venipuncture pain. The condition of the skin at the site of local anesthetic application was also observed to evaluate any side effects of the intervention (e.g., skin flare, color change). After two venous cannulations, participants rated pain during the intravenous cannula insertion on a visual analog scale (VAS 0–100 mm 0 mm, no pain 100 mm, intolerable pain) and verbal rating scale (VRS 1–4 1, no pain 4, intolerable pain). In all the patients, the order of venous cannulations followed the allocated group manner. Just before anesthetic induction, the tape and cream were removed and two 20 gauge Surflo® ETFE intravenous catheters (Terumo Corp, Tokyo, Japan) were inserted at the locally anesthetized areas one by one. The timings and doses of local anesthetic applications were decided according to their respective manufacturers’ instructions in a rigorous manner. All participants were randomly allocated, according to computer randomization, to EL group: received venipuncture at EMLA cream site firstly and lidocaine tape site secondarily, or LE group: received venipuncture at lidocaine tape site firstly and EMLA cream site secondarily (Fig. According to manufacturers’ instructions strictly, 1 g of 5% EMLA cream®, containing 25 mg of lidocaine and 25 mg of prilocaine per gram (Sato Seiyaku, Tokyo, Japan), was applied on the dorsum of one hand and covered by Tegaderm™ transparent film dressing (3 M Medical, Maplewood, MN) 60 min before entering the operation room, while a lidocaine tape (YouPatch tape® 18 mg, Yutoku Yakuhin, Saga, Japan) was applied on the dorsum of the other hand 30 min before operating room entrance for all participants. Patients with severe hepatic, renal, and cardiac diseases which might influence drug metabolism were also excluded. Exclusion criteria were patients who had local anesthetic allergy and skin abnormalities at the site of venipuncture. Eligible participants were patients aged 16 years and above, American Society of Anesthesiologists physical status I–III, who required two venous access lines during elective surgery under general anesthesia. Written informed consents were received from all patients before participation in this study. The study was approved by the institutional review board of Tomakomai City Hospital, Japan (approval code: 1605) and was registered in the UMIN-Clinical Trials Registry (UMIN trial ID: UMIN000023030). This single-center, prospective, randomized, interventional study was conducted at Tomakomai City Hospital, Hokkaido, Japan, from July 2016 to March 2017. UMIN Clinical Trials Registry, UMIN000023030. Our results strongly suggest that EMLA cream is more effective for venipuncture pain relief than lidocaine tape. We conducted a comparative study to elucidate the efficacy of EMLA cream for venipuncture-pain comparing with lidocaine tape in the same patients. The local skin adverse events were observed in five patients at EMLA cream applied hands. The VRS of EMLA cream was also significantly lower than that of lidocaine tape (2 vs 2, p = 0.002, 95% CI − 0.8 to − 0.2). The VAS of EMLA cream was significantly lower than that of lidocaine tape (4 vs 17, p = 0.001, 95% CI − 25 to − 6). Resultsĭata from 24 patients were analyzed. After cannulation, participants evaluated the pain by visual analog scale (VAS) and verbal rating scale (VRS).The primary outcome was VAS, and the secondary outcome was VRS. Before anesthetic induction, local anesthetics were removed followed by venous cannulations. In LE group, participants, conversely, received venipuncture at lidocaine tape site firstly. In the EL group, participants received venipuncture at EMLA cream site firstly. Local anesthetics were strictly applied according to their manufacturers’ instruments, respectively. Participants received EMLA cream at one side dorsum of hand and lidocaine tape at another dorsum of hand before entering operation room. Participants were randomly allocated into EL or LE group. The aim of this study is to accurately evaluate the efficacy of EMLA cream for venipuncture pain relief compared with lidocaine tape in the same patients. But these studies did not elucidate the effect of EMLA exactly, because there were large individual differences in pain sensitivity. Eutectic mixture local anesthetics (EMLA) has been used to reduce this pain, and various studies have been conducted to evaluate the efficacy of EMLA. Although venous cannulation is imperative during perioperative period, it inevitably causes venipuncture pain.
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