Background

To justify the use of the lidocaine/tetracaine medicated patch or peel as a preventive treatment for reducing pain and discomfort in adults and children. We reviewed randomized controlled trials (RCTs) to evaluate the efficacy and safety of the lidocaine/tetracaine medicated patch or peel compared with placebo.

Methods

Ten RCTs (574 patients) were included in this systemic review. Relevant studies were identified through searches of MEDLINE, SCOPUS and the Cochrane database library. The outcome was the adequacy of cutaneous anesthesia reflected in the patient's assessment of pain intensity during minor dermatologic procedures and adverse effects after application of the lidocaine/tetracaine medicated patch or peel versus placebo.

Results

The efficacy of the lidocaine/tetracaine patch or peel was consistently very significantly beneficial 30 or 60 minutes after the application compared to placebo (Relative risk, RR: 2.5; Number needed to treat, NNT: 2.2). We did not identify any difference in the effectiveness of adequate analgesia between the lidocaine/tetracaine patch and peel (the number needed to treat or to harm, NNT 2.4 vs. 2.0). No serious side effects or adverse events were observed with the lidocaine/tetracaine medicated patch or peel and placebo. Minor skin reactions were transient and resolved without treatment (Odd ratio, OR: 1.4 and 95% confidence interval, CI: 0.9-2.1; NNT: 14.9).

Conclusions

The lidocaine/tetracaine medicated patch or peel is a well accepted, effective and safe method for minor dermatologic procedures based on pooled data of trials in terms of adequacy of cutaneous anesthesia and adverse effects.

Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.

Background

Postoperative nausea and vomiting (PONV) remains a challenge for patients and health professionals despite various newly developed prophylactic interventions. We reviewed the efficacy and safety of ramosetron in randomized controlled trials (RCTs) for the prevention of PONV.

Methods

We reviewed 18 randomized controlled trials investigating the efficacy and safety of ramosetron in comparison with placebo or any other drugs. Relevant studies were searched in the MEDLINE, SCOPUS, and the Cochrane database libraries. Our end points of concern were prevention of PONV and adverse effects as dichotomous data.

Results

The prophylactic effect of 0.3 mg ramosetron was observed in early PON (relative risk, RR: 0.4; 95% CI 0.3-0.6), early POV (RR: 0.3; 95% CI 0.1-0.6), late POV (RR: 0.3; 95% CI 0.1-0.6), but not late PON (RR: 0.7; 95% CI 0.5-1.0). Compared with placebo, the efficacy of 0.3 mg ramosetron in adults and 6 µg/kg in children were consistently beneficial in preventing PONV overall (RR: 0.4; 95% CI: 03-0.6). The effects of 0.3 mg ramosetron and 3 mg granisetron were similar. No serious side effects or adverse events resulted from ramosetron and other active drugs, and incidence was similar to those of the placebo group.

Conclusions

Ramosetron is effective and safe in children and adults without serious adverse effects compared with placebo or other active drugs, as shown in pooled data of RCTs, in terms of the prevention of PONV.

Purpose

Many surgical patients are admitted to the intensive care unit (ICU), resulting in an increased demand, and possible waste, of resources. Patients who undergo liver resection are also transferred postoperatively to the ICU. However, this may not be necessary in all cases. This study was designed to assess the necessity of ICU admission.

Methods

The medical records of 313 patients who underwent liver resections, as performed by a single surgeon from March 2000 to December 2010 were retrospectively reviewed.

Results

Among 313 patients, 168 patients (53.7%) were treated in the ICU. 148 patients (88.1%) received only observation during the ICU care. The ICU re-admission and intensive medical treatment significantly correlated with major liver resection (odds ratio [OR], 6.481; P = 0.011), and intraoperative transfusions (OR, 7.108; P = 0.016). Patients who underwent major liver resection and intraoperative transfusion were significantly associated with need for mechanical ventilator care, longer postoperative stays in the ICU and the hospital, and hospital mortality.

Conclusion

Most patients admitted to the ICU after major liver resection just received close monitoring. Even though patients underwent major liver resection, patients without receipt of intraoperative transfusion could be sent to the general ward. Duration of ICU/hospital stay, ventilator care and mortality significantly correlated with major liver resection and intraoperative transfusion. Major liver resection and receipt of intraoperative transfusions should be considered indicators for ICU admission.