Clinical performance of early warning scoring systems for identifying sepsis among anti-hypertensive agent users.

BACKGROUND: Little is known about the accuracy of the quick Sequential Organ Failure Assessment (qSOFA) and the National Early Warning Score (NEWS) in identifying sepsis patients with a history of hypertension on anti-hypertensive agents, which affect vital signs as components of the scoring systems. We aimed to examine the ability of qSOFA and NEWS to predict sepsis among anti-hypertensive agent users by comparing them with non-users. METHODS: We retrospectively identified adult patients (aged ≥18years) with suspected infection who presented to an emergency department (ED) of a large tertiary medical center in Japan between April 2018 and March 2020. Suspected infection was defined based on the chief complaint of fever, high body temperature, or the clinical context on arrival at the ED. We excluded patients who had trauma or cardiac arrest, those who were transported to other hospitals after arrival at the ED, and those whose vital signs data were mostly missing. The predictive performances of qSOFA and NEWS based on initial vital signs were examined separately for sepsis, ICU admission, and in-hospital mortality and compared between anti-hypertensive agent users and non-users. RESULTS: Among 2900 patients with suspected infection presenting to the ED, 291 (10%) had sepsis, 1023 (35%) were admitted to the ICU, and 188 (6.5%) died. The prediction performances of qSOFA and NEWS for each outcome among anti-hypertensive agent users were lower than that among non-users (e.g., c-statistics of qSOFA for sepsis, 0.66 vs. 0.71, p = 0.07; and for ICU admission, 0.70 vs. 0.75, p = 0.01). For identifying sepsis, the sensitivity and specificity of qSOFA ≥2 were 0.43 and 0.77 in anti-hypertensive agent users and 0.51 and 0.82 in non-users. Similar associations were observed for identifying ICU admission and in-hospital mortality. Regardless of the use of anti-hypertensive agents, NEWS had better prediction abilities for each outcome than qSOFA. CONCLUSION: The clinical performance of qSOFA and NEWS for identifying sepsis among anti-hypertensive agent users was likely lower than that among non-users.

The Effect of Inhaler Aromatherapy on Invasive Pain, Procedure Adherence, Vital Signs, and Saturation During Port Catheterization in Oncology Patients.

The study was conducted to evaluate the effect of inhaler aromatherapy on invasive pain, procedure adherence, vital signs, and saturation during port catheter insertion among patients diagnosed with cancer. The study was conducted in a nonrandomized controlled trial. Sixty patients including 30 patients in the intervention group and 30 patients in the control group, who were subjected with the same local anesthetic protocol, were included in the study. Aromatic mixture prepared by diluting orange, chamomile, and lavender oil in 70 mL distilled water was inhaled by the intervention group during the procedure. The data of the study were collected by using questionnaire, vital follow-up form, and visual analog scale. The patients in the intervention and control groups were similar in terms of sociodemographic and disease characteristics (P > .05). It was determined that inhaler aromatherapy applied to patients in the intervention group decreased pain experienced during the procedure and facilitated the procedure adherence (P < .05); however, it did not affect vital signs and saturation (P > .05). It can be recommended to administer inhaler aromatherapy with pharmacological therapies during catheterization procedure since it decreases invasive pain and facilitates the procedure adherence.

Risk Factor for Vital Signs Fluctuation during Colonoscopy under Conscious Sedation Consisting of Midazolam and Meperidine.

BACKGROUND: Sedatives or analgesics are widely used to relieve a patient's discomfort during colonoscopy (CS). Although cardiopulmonary adverse events are sometimes experienced during the examination, the risk factors for vital signs fluctuation (VSF) have not been fully elucidated. This study thus aimed to identify the risk factors for VSF during the examination, as well as to evaluate the frequency and the degree of VSF. SUMMARY: A total of 755 consecutive subjects who received CS under endoscopist-administrated sedation using midazolam, meperidine, or combination of both were retrospectively analyzed. We assessed the distribution of vital signs during the procedure and frequency of VSF. To identify independent risk factors, we analyzed the association between VSF and subjects' characteristics and procedure information using the multivariate logistic regression model. Consequently, VSF was observed in 17% of all; hypotension and oxygen desaturation was observed in 13 and 5%, respectively. However, we could achieve the purpose of all procedure and, no one required hospitalization or extension of hospital stay. Multivariate analysis revealed that age (OR 1.05 [95% CI 1.04-1.07]), being female (OR 1.78 [95% CI 1.19-2.70]), and use of midazolam (OR 5.06 [95% CI 3.18-8.08]) were independent risk factors for VSF.

Recognition of Sympathetic Crashing Acute Pulmonary Edema (SCAPE) and use of high-dose nitroglycerin infusion.

Sympathetic Crashing Acute Pulmonary Edema (SCAPE), or flash pulmonary edema, is the extreme end of the acute pulmonary edema spectrum. A sympathetic surge occurs as a result of decreased systemic perfusion resulting in further increases in afterload, causing the patient to decompensate. Patients can decompensate quickly, therefore patients require rapid interventions. The use of high-dose nitroglycerin (HDN) has been a topic of interest as it is believed to achieve preload and afterload reduction. However, its use continues to be controversial due to concerns of drug induced hypotension, syncope or paresthesia. Although there are Free Open Access Medical Education (FOAM) based podcasts as well as few studies to suggest the use of HDN, the evidence is limited by statistical flaws, incomplete dosing parameters and inconsistent methods of administration. In order to address these limitations, a protocol at our ED was created to ensure the safe and effective use of HDN. Here, we present a case of HDN use for the management of SCAPE based on this protocol.

Dexmedetomidine as an Additive to Local Anesthesia: A Step to Development in Dentistry.

PURPOSE: The study aimed to compare the effect of dexmedetomidine added to lidocaine against epinephrine added to lidocaine on local anesthetic potency and to look for future prospects of dexmedetomidine as an additive to local anesthesia in dentistry. MATERIALS AND METHODS: The study included 25 healthy volunteers in whom extraction of all first premolars was scheduled as part of their orthodontic treatment plan. In this split-mouth, double-blind, crossover, randomized controlled trial, patients were randomized into 2 groups: Group 1 received injection lidocaine plus dexmedetomidine, and group 2 was administered lidocaine plus epinephrine. Patients were assessed for the onset of action of anesthesia, duration of analgesia, pain perception, and vital signs. RESULTS: The mean values (±standard deviations) for the onset of anesthetic action in groups 1 and 2 were 113 ± 24.9 and 141 ± 34.8 seconds, respectively, for the mandible. For the maxilla, the mean values were 113 ± 24.9 seconds for group 1 and 165 ± 43.8 seconds for group 2. The duration of anesthesia was longer in group 1 (lidocaine plus dexmedetomidine), in which the requirement for the first analgesic on request was seen after a longer time interval, when compared with group 2 (lidocaine plus epinephrine). Pain perception elicited statistically significant results with less perception of pain in group 1 (lidocaine plus dexmedetomidine). The vital parameters remained stable, and the results were not statistically significant. CONCLUSIONS: In this study, we observed that the addition of dexmedetomidine to lidocaine for maxillary and mandibular nerve blocks significantly prolonged the block duration and shortened the onset of action, as well as improved postoperative analgesia in terms of the need for fewer analgesics in the postoperative period. Furthermore, the vital parameters remained stable and no complications were encountered. The findings were supportive of the use of dexmedetomidine as an adjunct to local anesthetics in dental procedures.

Developing an objective method for analyzing vital signs changes in neonates during general anesthesia.

BACKGROUND: Commonly used general anesthetics are considered to be neurotoxic to the developing rodent brain, leading to poor long-term outcome. However, it is unclear whether these rodent studies can be extrapolated to the human neonate. Given that anesthesia for urgent neonatal surgery cannot be avoided, it is vitally important to assess other factors that may impact neurological outcome following anesthesia and surgery. OBJECTIVE: The purpose of this study is to identify thresholds for detecting vital sign deviations, which may have the potential for affecting neurological outcome following anesthesia and surgery in neonates. These data may be suitable to identify targets for prospective quality improvement projects and guide future research for strategies to reduce detrimental neurocognitive outcomes. METHODS: A retrospective analysis of vital sign data was performed for neonates (age ≤28 days), undergoing noncardiac surgery over a 4-year period (2010-2013). Thresholds for detecting bradycardia, tachycardia, hypothermia, hyperthermia, hypertension, hypotension, hypocarbia, hypoxemia, significant changes in mean arterial blood pressure, and periods of high inspired oxygen concentration, were proposed. Selected chart review, to identify additional risk factors, and identify sources of data artifact, was performed for 224 cases. RESULTS: Data from 435 procedures in neonates, with median (IQR [range]) ages of 6 (2-16 [0-28]) days were available for analysis. Five (3-6 [0-12]) rule deviations per case were observed; only 11 cases had no rule deviations. Hypothermia was observed in 285/435 (70%), moderate hypocapnia in 298/430 (69%), and severe hypotension in 270/435 (62%) cases. CONCLUSION: An objective method of comparing cases has been created with a method to automatically identify neonatal vital sign deviations. With further validation the method has the potential to be a powerful tool to drive future quality improvement projects in neonatal anesthesia.

The pharmacokinetic profile, tolerability and safety of the iodinated, non-ionic, dimeric contrast medium Iosimenol 340 injection in healthy human subjects.

BACKGROUND: Iosimenol 340 injection is a new isotonic iodinated contrast medium for X-ray angiography. PURPOSE: To investigate the pharmacokinetics and biotransformation, tolerability, and safety of Iosimenol 340 in healthy human subjects. MATERIAL AND METHODS: Twenty-four subjects were enrolled and randomized to receive either Iosimenol 340 (0.5, 1.5 or 3.0 mL/kg) or placebo (0.9% saline). In each dosing group, six subjects received Iosimenol 340 and two subjects received placebo. Safety was assessed by physical examination, vital signs, electrocardiography, and laboratory tests. Adverse events were recorded throughout the study up to 14 days after dosing. Blood samples were collected from 10 min before until 48 h after the start of dosing and urine samples were collected from 15 min before until 96 h after the start of dosing. Iosimenol was quantified in plasma and urine by measuring iodine concentrations with X-ray fluorescence. High-performance liquid chromatography was used to assess iosimenol biotransformation. RESULTS: Mean half-lives (mean ± standard deviation [SD]) of iosimenol were 0.17 ± 0.08 h (10.2 ± 4.8 min) and 2.01 ± 0.32 h for distribution and terminal elimination phases, respectively. The apparent volume of distribution was 0.27 ± 0.05 L/kg, indicating distribution to the extracellular fluid volume. Iosimenol was excreted within 24 h without any sign of metabolic transformation. Thirty-two adverse events were observed in 14 subjects. All were mild or moderate, and were transient in nature. CONCLUSION: Iosimenol was not metabolized, had a distribution volume corresponding to the extracellular space, and was rapidly excreted through the kidneys by glomerular filtration. The area under the plasma concentration curve and the peak plasma concentration was proportional to dose, while clearance was independent of dose. Iosimenol 340 was well tolerated.

A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 suppositories for 14 days.

AIMS: The 1R,2S stereoisomer of methoxamine hydrochloride, NRL001, is a highly selective α1-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone. This study investigated the steady state pharmacokinetics (PK) and safety of 2 g rectal suppositories containing NRL001 in different strengths (7.5, 10, 12.5 or 15 mg). METHODS: Healthy volunteers aged 18-45 years received 14 daily doses of NRL001 2 g suppositories or matching placebo. In each dose group nine participants received NRL001 and three received placebo. Blood samples to determine NRL001 concentrations were taken on Days 1, 7 and 14. Cardiovascular parameters were collected via electrocardiograms, Holter monitoring (three lead Holter monitor) and vital signs. RESULTS: Forty-eight volunteers were enrolled; 43 completed the study and were included in the PK analysis population. AUC and Cmax broadly increased with increasing dose, Tmax generally occurred between 4.0 and 5.0 h. Although the data did not appear strongly dose proportional, dose proportionality analysis did not provide evidence against dose proportionality as the log(dose) coefficients were not significantly < 1. NRL001 did not accumulate over time for any dose. Increasing NRL001 concentrations were related to changes in vital sign variables, most notably decreased heart rate. The most commonly reported adverse events (AEs) in the active treatment groups were paraesthesia and piloerection. CONCLUSIONS: Treatment with NRL001 was generally well tolerated over 14 days once daily dosing and plasma NRL001 did not accumulate over time. Treatment was associated with changes in vital sign variables, most notably decreased heart rate. AEs commonly reported with NRL001 treatment were events indicative of a systemic α-adrenergic effect.

Alogliptin improves steroid-induced hyperglycemia in treatment-naïve Japanese patients with chronic kidney disease by decrease of plasma glucagon levels.

BACKGROUND: Chronic kidney disease (CKD) is a risk factor for end-stage renal failure and cardiovascular disease, and a strategy to counteract CKD must be established. CKD caused by immunological abnormalities is treated by steroids, frequently resulting in steroid diabetes. Although insulin is the most effective drug against steroid diabetes, administering it to patients can be difficult. Dipeptidyl peptidase-4 (DPP-4) inhibitors were developed for diabetes mellitus with a new mechanism of action. However, their efficacies and mechanisms of action for steroid diabetes are unclear. MATERIAL AND METHODS: We studied 11 CKD patients treated with steroids admitted to our hospital (3 men and 8 women; age, 66.0 ± 15.9 years). DPP-4 inhibitor alogliptin was administered for steroid diabetes. Levels of markers related to glucose metabolism were measured before alogliptin treatment and after alogliptin treatment, before the prednisolone dose was reduced. RESULTS: Alogliptin treatment significantly increased plasma glucagon-like peptide-1 (GLP-1) levels from 1.16 ± 1.71 pmol/L to 4.48 ± 1.53 pmol/L and significantly reduced levels of plasma glucose recorded 2 h after lunch and hemoglobin A1c (HbA1c). No significant differences were seen in insulin secretory ability of homeostasis model assessment (HOMA) (HOMA-ß) and insulin resistance index of HOMA (HOMA-R) before and after alogliptin treatment. In contrast, alogliptin treatment significantly decreased plasma glucagon levels, from 116.1 ± 38.7 pg/mL to 89.6 ± 17.3 pg/mL. Moreover, there were significant correlations among HbA1c, GLP-1, and glucagon levels. CONCLUSIONS: Alogliptin improves steroid-induced hyperglycemia by decrease of glucagon levels through an increase in plasma GLP-1 levels.

Comparison of the effects of lidocaine and fentanyl in epidural anesthesia in dogs.

The study included 12 clinically healthy, adult male dogs of various breeds, admitted to our clinic for castration. After general anesthesia with sevoflurane, we administered epidural fentanyl (1 mcg/kg) to fentanyl group, while lidocaine group was given Lidocaine (3 mg/kg) through epidural administration. When hemodynamic parameters were stabilized, first measurements were recorded at minutes 0, 15, 30, 60 in both groups, which included Heart Rate (HR), body temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), sodium (Na+), potassium (K+), glucose (GLC), and hemoglobin (HB) measurements. In addition, serum samples were obtained from arterial blood at the same measurement times, and pH, pO2, pCO2, HCO3, %O2 Saturation, BE levels were measured. For hematological analysis, WBC, RBC, HCT, THR counts were performed. For serum biochemical analysis, venous blood samples were collected at minutes 0 and 60 and CK, TP, UREA, ALT, AST, ALB, GGT, CRE, CK-MB parameters were assessed using auto-analyzer. Moreover, cortisol levels were measured in the samples collected at minutes 0, 30, and 60.Mean arterial blood pressure values measured at minutes 15, 30 and 60 were found significantly lower in the fentanyl group (p<0.01). In conclusion, we suggest that epidural anesthesia with lidocaine and fentanyl can provide an effective and safe option in high-risk groups (Tab. 5, Fig. 1, Ref. 24).

[Heliox augmented mechanical ventilation in the treatment of premature infants with respiratory distress syndrome]. / Wentylacja mechaniczna z zastosowaniem helioxu w leczeniu wczesniaków z zespolem zaburzen oddychania.

OBJECTIVE: The aim of the study was to assess the influence of mechanical ventilation with helium-oxygen mixture (heliox) on basic vital signs, oxygenation, acid-base balance and respiratory mechanics in newborns with respiratory distress syndrome (RDS), previously treated with surfactant. MATERIAL AND METHODS: The study was carried out in preterm newborns with respiratory failure requiring mechanical ventilation due to RDS, requiring Fi02>0.4 after a single dose of surfactant. Patients were ventilated using PC-SIMV Parameters of mechanical ventilation, respiratory function, oxygenation, acid-base balance and vital signs were recorded at baseline, one hour during and one hour after heliox ventilation. RESULTS: Ten newborns with RDS were enrolled in the study Mechanical ventilation with heliox did not affect vital signs and patient general condition remained stable during and after ventilation with heliox. Mechanical ventilation with heliox was associated with a statistically significant increase in tidal volume (mean 5.48 vs. 6.55 ml/kg). There were no significant changes in minute ventilation and peak expiratory flow rate. Mechanical ventilation with heliox allowed the use of significantly lower fractions of inspired oxygen (mean 0.55 vs. 0.35), with a significant decrease in the oxygenation index (mean 8.77 vs. 5.02) and alveolar-arterial oxygen tension difference (mean 263.81 vs. 113.28 mm Hg). After ventilation with this gas mixture was stopped, the patients required higher Fi02, 01 and AaD02 levels increased. CONCLUSIONS: Mechanical ventilation with heliox was safe, improved oxygenation and caused an increase in tidai, volume in newborns with RDS previously treated with surfactant.

The effects of aromatherapy with thyme oil on disease symptoms, vital findings, and hemodynamic parameters in COVID-19 patients.

OBJECTIVE: To determine the effect of aromatherapy with thyme oil on disease symptoms, vital signs, and hemodynamic parameters in COVID-19 patients. METHODS: We conducted the randomized controlled trial with 140 (experimental group=70, control group=70) COVID-19 patients. Patients admitted to the COVID-19 service of the Batman Training and Research Hospital were included in the sample between 31.01 - 31.08 2022. Patients in the experimental group inhaled thyme oil 3 times a day during 5 days. At the end of day 5, symptoms and hemodynamic parameters were measured as posttest. Vital signs were measured 3 times a day during 5 days. The control group only received routine treatment. RESULTS: Thyme oil was found to be effective in relieving symptoms of shortness of breath, dizziness, secretion, diarrhea, weakness, loss of appetite, cough, headache and muscle joint pain. Although there was improvement in the symptoms of nausea-vomiting, runny nose and loss of taste-smell, the effect was not statistically significant. Thyme oil significantly decreased body temperature, pulse rate and respiratory rate (p<0.05), increased SPO 2 (p<0.05), and did not affect systolic and diastolic blood pressure (p>0.05). It had a significant effect on the regulation of pH, decreased CO2 and increased O2 significantly (p<0.05). CONCLUSION: Thyme oil aromatherapy was effective in reducing symptoms, regulating vital signs and hemodynamic parameters. Accordingly, thyme oil is recommended as non-pharmacological treatment method in COVID-19 patients.

Low-dose ketamine analgesia: patient and physician experience in the ED.

OBJECTIVE: Low-dose ketamine (LDK) may be useful for treatment for opioid-tolerant patients. We conducted a survey of patients and their treating clinicians regarding LDK for analgesia. METHODS: Survey data included the following: vital signs and pain score before and after LDK, demographics, and adverse effects. Treating physicians were queried about reasons for use of LDK and overall satisfaction. RESULTS: Twenty-four patients were enrolled: 21 received LDK for analgesia, and 3 received LDK for sedation. Pain level on a visual analog scale (range, 1-10) after LDK was significantly decreased from 8.9 ± 2.1 to 3.9 ± 3.4 (P < .0001). Change in vital signs after administration of LDK was not statistically significant. Overall patient satisfaction with LDK was 55%, and overall physician satisfaction was 72%. Sixteen (67%) of patients would prefer LDK again, and 23 (96%) of physicians would use LDK again for analgesia. Four patients reported an adverse experience, but there were no emergence reactions. Race subanalysis revealed no difference in pain reduction, but whites were least satisfied compared with black and Hispanic patients (P = .02). Physician reasons for using LDK included opioid failure (88%), concern for respiratory depression (17%), concern for multiple opioid allergies (13%), and concern for hypotension (8%). Most (96%) physicians believed that LDK is underused. CONCLUSION: Low-dose ketamine may decrease patients' perception of pain. Most were satisfied with LDK for this purpose and would use it again. Whites were least satisfied with the use of LDK for analgesia. Physicians believed that ketamine is underused.

Intramuscular ziprasidone: influence of alcohol and benzodiazepines on vital signs in the emergency setting.

BACKGROUND: Ziprasidone is a second-generation antipsychotic (SGA) approved for agitation. Few previous studies have examined ziprasidone in the emergency department (ED). For instance, it is unknown how often emergency physicians prescribe ziprasidone, whether it is typically prescribed in combination with a benzodiazepine, or whether use of intramuscular (i.m.) ziprasidone and benzodiazepines affects vital signs compared to i.m. ziprasidone alone. OBJECTIVE: Our aims were to determine the demographics of patients receiving ziprasidone in an urban-suburban ED; the relative frequency with which ziprasidone is prescribed; and the effects on vital signs, repeat medication dosage, and lengths of stay. METHODS: This is a multicentered structured chart review from 2003 to 2010 of ziprasidone use at two hospitals. If documented, vital signs were compared in patients who received concurrent benzodiazepines and in those who did not, and in patients who ingested alcohol and in those who did not. RESULTS: Patients on 95 visits received ziprasidone during the study period, with one third of these receiving accompanying benzodiazepines. Forty-nine unique patients who were treated with i.m. ziprasidone had documented vital signs. In these patients, alcohol intoxication was associated with decreased oxygen saturations irrespective of benzodiazepines. Concurrent benzodiazepines had no other deleterious effect on vital signs but resulted in longer ED stays. CONCLUSIONS: This study suggests that many ED physicians, who commonly prescribe a benzodiazepine with a first-generation antipsychotic like haloperidol, have transferred this practice to SGAs like ziprasidone. In this sample, this pairing did not adversely affect vital signs but was associated with marginally longer ED stays. Caution should be exercised when treating alcohol-intoxicated patients with ziprasidone, as this can decrease oxygen saturations.

Intermittent manually controlled versus continuous infusion of propofol for deep sedation during interventional endoscopy: a prospective randomized trial.

INTRODUCTION: Beside the traditional, intermittent bolus application of propofol, continuous propofol infusion via infusion pump is an alternative procedure for deep sedation during long-lasting interventional endoscopy. However, up to now, there are no randomized comparisons for gastrointestinal endoscopy. METHODS: One hundred patients (ERCP: n = 60, EUS: n = 40) were randomly assigned to receive intermittent bolus application ("bolus group") or continuous infusion ("perfusor group") of propofol sedation after induction with 3 mg midazolam for deep sedation. Patients in the bolus group received an initial propofol dose according to body weight (bw <70 kg: 40 mg; bw ≥ 70 kg 60 mg). In the perfusor group, bw-adapted, continuous propofol infusion (6 mg/kg) via the Injectomat 2000 MC (Fresenius-Kabi) was administered after an initial bolus of 1 mg/kg. Vital signs, dose of propofol, patient cooperation (VAS 1-10), sedation depth, and the recovery time as well as the quality of recovery were evaluated. RESULTS: Total propofol dose in the bolus group 305 ± 155 mg (100-570 mg) and in the perfusor group 343 ± 123 mg (126-590 mg, p = 0.5) were comparable. Oxygen saturation below 90% was seen in four patients of each group, with no need for assisted ventilation. Arterial blood pressure <90 mmHg was documented in two patients in the bolus group and seven patients in the perfusor group (p = 0.16). Patients' cooperation was rated as good in both groups (bolus group, 9.1 ± 0.9; perfusor group, 8.9 ± 1; p = 0.17). Recovery time was significantly shorter in the bolus group compared with the perfusor group (19 ± 5 versus 23 ± 6 min, p < 0.001) whereas the quality of recovery was nearly identical in both groups. CONCLUSION: Both sedation regimens allow nearly identical good controllability of propofol sedation. However, recovery time was significantly slower and hypotension was tended to occur more often in the perfusor group.

[Pethidine for labor analgesia; monitoring of newborn heart rate, blood pressure and oxygen saturation during the first 24 hours after the delivery]. / Petydyna w analgezji porodu; monitorowanie czynnosci serca, cisnienia tetniczego i saturacji w ciagu pierwszych 24 godzin zycia noworodka.

BACKGROUND: There is no information about an effect of pethidine labor analgesia on newborn vital signs in the first hours after the delivery. OBJECTIVES: The aim of the study was to assess changes in heart rate, blood pressure and oxygen saturation during the first 24 hours of life in neonates born after using pethidine for labor analgesia. METHODS: 55 full-term neonates, 34 from intramuscular pethidine labor anesthesia in doses 50-100 mg and 21 born to mothers without any pharmacological form of anesthesia, were studied. Heart rate, oxygen saturation and blood pressure (SBP and DPB) were monitored using a Nellcor Oxi Max monitor N5500 (Tyco Healthcare), and recorded at 1, 6, 12 and 24 hours. RESULTS: No significant differences in the heart rate (144; 139; 141; 142,5 versus 142; 140,5; 138; 141 beats/minute), oxygen saturation (97%; 98%; 98%; 98,5%; versus 98%, 98%, 98%, 98%), SBP (66,5; 67; 66; 66,5 versus 68,5; 65; 64; 64,5 mmHg) and DBP (33,5; 35; 37; 40 versus 34; 32; 32; 38 mmHg) at 1, 6, 12 and 24 hours between pethidine and controls groups were found. CONCLUSIONS: Intramuscular pethidine analgesia during the first stage of labor in doses 50-100 mg does not significantly modify the oxygen saturation, heart rate and blood pressure in infants during the first 24 hours of their life.

Appropriate infliximab infusion dosage and monitoring: results of a panel meeting of rheumatologists, dermatologists and gastroenterologists.

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: Infliximab is an effective treatment for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis and national and international guidelines have been developed for each indication. WHAT THIS STUDY ADDS: This study is the first study which compared current international, national and local guidelines from the medical specialties involved in the treatment with infliximab on the following topics: indication, dosage, synergy and monitoring of vital signs. AIMS: Infliximab, an anti-TNF biologic agent, is currently indicated and reimbursed for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis. Development of national and international guidelines for rheumatology, gastroenterology and dermatology, was mostly based on clinical studies and expert opinion. The aim of this study was to compare available guidelines and local protocols for rheumatology, dermatology and gastroenterology, regarding dosage of infliximab, synergy of infliximab with concomitant medication and monitoring of vital signs during infliximab administration, for achieving optimal care. METHODS: Current international, national and local guidelines on the use of infliximab were reviewed and compared, differences and shortcomings were identified, and optimal treatment schedules discussed during a meeting (July 2008) of clinical experts and researchers from three departments of a Dutch university hospital. RESULTS: Recommended dosages of infliximab are not equal for different indications. Loss of response to infliximab is a common problem encountered within the three medical specialties, but indications for adjustments in treatment schedules are lacking in all of the guidelines. Monitoring of vital signs (blood pressure, pulse, temperature) during infusion with infliximab is common practice and recommended by some guidelines. Routine measurement of vital signs is not of any value in predicting or recognizing acute infusion reactions, in our experience, and this is confirmed by literature on inflammatory bowel disease. CONCLUSION: Different indications encompass different dosing schedules. National and internal guidelines do not provide advice regarding loss of response. Routine measurement of vital signs during infusion is not valuable in detecting acute infusion reactions and should only be performed in case of an acute infusion reaction. These topics need to be studied in future studies and covered in future guidelines.

Dose response of sodium nitrite on vasoactivity associated with HBOC-201 in a swine model of controlled hemorrhage.

Sodium nitrite (NaNO(2)) was evaluated in a 55% EBV hemorrhage swine model to mitigate the increased blood pressure due to HBOC-201. Animals were resuscitated by three 10 ml/kg infusions of either HBOC-201 or Hextend with and without NaNO(2). All vital signs, coagulation and blood chemistry were measured for 2 hr. HBOC-201-vasoconstriction was attenuated only after the first 10.8 µmol/kg NaNO(2) infusion. Complete abolition was obtained with the highest 3 NaNO(2) dose, but side effects were observed. There was no reduction in platelet function due to NaNO(2). NaNO(2) ability to reduce HBOC-201 vasoactivity was transient and 10.8 µmol/kg NaNO(2) seems an acceptable dose for further investigation.

Inhaled methoxyflurane and intranasal fentanyl for prehospital management of visceral pain in an Australian ambulance service.

OBJECTIVE: This study analysed the analgesic effect and changes in vital signs associated with administration of inhaled Methoxyflurane (MTX) and/or intranasal Fentanyl (INF) for prehospital management of visceral pain. METHOD: A retrospective, observational study reviewing 1024 randomly selected records of patients with presumed visceral pain administered MTX (465), INF (397) or both (162) by the Western Australian Ambulance Service between January 2004 and February 2006. Clinical variables assessed included systolic blood pressure, pulse rate, respiration rate and Glasgow Coma Scale score. Pain was assessed utilising Visual/Verbal Analogue Scale pain scores. RESULTS: Overall effects on vital signs appeared favourable 5 min after use and at hospital arrival with either agent alone or in combination. As sole agents, MTX produced the greatest initial pain scores reduction (2.0 (1.7 to 2.2) vs 1.6 (1.4 to 1.8)) (mean (95% CI), and INF provided greater pain reduction by hospital arrival (3.2 (2.9 to 3.5) vs 2.5 (2.1 to 2.9)). While both agents were effective, INF provided a greater pain score reduction for cardiac (3.0 (2.6 to 3.4) vs 2.3 (1.8 to 2.8)), female (3.4 (2.9 to 4.0) v 2.5 (2.0 to 3.0)) and age 75+ patients (3.2 (2.5 to 3.8) vs 1.8 (1.0 to 2.5)). Combined use of agents was not advantageous. CONCLUSIONS: MTX and INF are effective agents for providing visceral pain analgesia in the prehospital setting. While MTX provided a more rapid onset of pain relief, INF provided superior analgesia after subsequent doses and in female, cardiac and older patients.

Review of the statistical analysis of the dog telemetry study.

In 2008, the PSI Toxicology Special Interest Group met to discuss the design and analysis of dog telemetry studies. The dog telemetry study is one component of the integrated cardiovascular assessment required by regulatory bodies. Although there are guidelines for these studies, little is said about the statistical analysis. With parameters of interest measured continually over time, in studies typically involving four dogs, the analysis is not straightforward. This has led to many different types of analysis being proposed in the literature, with many different methods applied within the pharmaceutical industry itself. This paper summarizes the PSI Toxicology group's discussions and recommendations around these issues.