Assessment of indomethacin oral spray for the treatment of oropharyngeal mucositis-induced pain during anticancer therapy.

PURPOSE: The efficacy and safety of indomethacin (IM) oral spray (OS) as a pain control therapy for oropharyngeal mucositis due to anticancer chemo- and radiotherapy were assessed in patients with head and neck carcinomas and haematological tumours. METHOD: We observed 35 patients (male/female, 20/15; 53 ± 17 years) with oropharyngeal mucositis who were treated with IM-OS preparation for pain relief at University of Tsukuba Hospital, Japan. Analgesic effects were assessed using the six-grade face scale for pain in 28 patients at the start of IM oral spray treatment. Systemic exposure was assessed by determining urinary excretions of IM in seven patients. RESULTS: Pain relief was achieved in 26 (93%) patients at 25 (5-60) min after applying the IM-OS preparation (15.6 ± 3.4 µg/kg) and analgesic effects were maintained for 120 (10-360) min. The pain was significantly decreased after using the spray (3.6 ± 0.7 vs. 2.4 ± 0.9, p < 0.01). Moreover, urinary IM excretion rates after applying the IM spray preparation were 1.8 ± 0.8% of the IM oral spray dose (130.5 ± 77.7 µg/kg/day), which was markedly lower than that following oral administration of IM (60%). No adverse events were observed following application of the spray. CONCLUSIONS: The present IM spray is an effective and safe preparation for pain relief and can be used as an alternative therapeutic option for oropharyngeal mucositis in cancer patients.

Analysis of trends and emergency activities relating to critical victims of the Chuetsuoki Earthquake.

INTRODUCTION: When a large-scale disaster occurs, it is necessary to use the available resources in a variety of sites and scenes as efficiently as possible. To conduct such operations efficiently, it is necessary to deploy limited resources to the places where they will be the most effective. In this study, emergency and medical response activities that occurred following the Chuetsuoki Earthquake in Japan were analyzed to assess the most efficient and effective activities. METHODS: Records of patient transports by emergency services relating to the Niigata Chuetsuoki Earthquake, a magnitude 6.8 earthquake that struck Japan on 16 July 2007 were analyzed, and interview surveys were conducted. RESULTS: The occurrence of serious injuries caused by this earthquake essentially was limited to the day the earthquake struck. A total of 682 patients were treated on the day of the quake, of which about 90 were hospitalized. Of the 17 patients whose conditions were life-threatening, three were rescued and transported to hospital by firefighters, three were transported by ambulance, and 11 were transported to hospital using private means. Sixteen people were subsequently transferred to other hospitals, six of these by helicopter. There was difficulty in meeting all of the requests for emergency services within 4 to 6 hours of the earthquake's occurrence. Most transports of patients whose conditions were life-threatening were between hospitals rather than from the scene of the injury. Transfers of critical patients between hospitals were efficient early on, but this does not necessarily mean that inter-hospital transfers were given higher priority than treatment at emergency scenes. CONCLUSION: During the acute emergency period following a disaster-causing event, it is difficult to meet all requests for emergency services. In such cases, it is necessary to conduct efficient activities that target critically injured patients. Since hospital transfers are matters of great urgency, it is necessary to consider assigning resource investment priority to hospital transfers during this acute period, when ambulance services may be insufficient to meet all needs. To deal with such disasters appropriately, it is necessary to ensure effective information exchange and close collaboration between ambulance services, firefighting organizations, disaster medical assistance teams, and medical institutions.

Assessment of clonidine orally disintegrating tablet for pre-anesthetic medication in pediatric surgery.

The purpose of this study is to assess orally-disintegrating (OD) tablet of clonidine hydrochloride (CL) for a pre-operative sedation in pediatric surgery. Sedation score and plasma CL concentration of OD formulation was compared with original preparation, CL lollipop, in pediatric patients. Fourteen patients (age: 3.9+/-2.3 years, weight: 16.9+/-5.0 kg) for OD group and 9 patients (age: 4.4+/-3.1 years, weight: 17.2+/-7.0 kg) for lollipop group received 4 microg/kg of CL preparation. Pre-operative sedation was evaluated by 5-point scoring systems at entering the operating room. Plasma CL concentrations were determined 120 min after administration of CL preparation. The changes in systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were also assessed before and after administration of CL preparation. Every patient in OD group had satisfactory sedation (sedation score: 2 and 3), whereas, 3 (33%) in lollipop group had unsatisfactory sedation (sedation score: 0 and 1). Plasma CL concentration in OD group was significantly higher than those in lollipop group (0.75+/-0.15 vs. 0.42+/-0.21 ng/ml, p<0.01). There was no significant difference in hemodynamic parameters (SBP, DBP and HR) between before and after administration of CL preparation in both OD and lollipop group. We conclude that OD is superior preparation of CL for pre-operative sedation in pediatric surgery.

Assessment of serum flecainide trough levels in patients with tachyarrhythmia.

The reported therapeutic range for trough flecainide concentration is 200-1000 ng mL(-1). Severe adverse events, such as ventricular arrhythmias, have occurred occasionally in patients whose serum flecainide exceeded 1000 ng mL(-1). However, the lower limit remains controversial. We have evaluated blood flecainide concentrations in patients with tachyarrhythmia who received the drug to control palpitation. We measured the flecainide trough levels and incidence and frequency of palpitation of 44 outpatients receiving oral flecainide (150-300 mg daily). Mean serum flecainide trough concentrations differed significantly between patients with (n = 14) and without (n = 30) palpitation (259.5 +/- 85.2 vs 462.2 +/- 197.7 ng mL(-1), P < 0.01). The frequency of palpitation decreased as the serum flecainide concentration increased. The incidence of palpitation was 65% at serum flecainide concentrations < 300 ng mL(-1) and 11% at > or = 300 ng mL(-1). QRS values were increased significantly in patients with serum flecainide < 300 ng mL(-1) compared with > or = 300 ng mL(-1) (0.110 +/- 0.016 s vs 0.093 +/- 0.019 s, P < 0.05). We concluded that to control paroxysm in patients receiving flecainide for tachyarrhythmia serum flecainide concentrations should be maintained at > or = 300 ng mL(-1).