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Is intravenous paracetamol a useful adjunct for intraoperative pain?  [cached]
Ali MA,Siddique S
theHealth , 2012,
Abstract: Background: Paracetamol is a safe and cost effective intravenous (IV) analgesic. This survey was conducted to assess the satisfaction of anesthetics with the intra-operative use of IV paracetamol as an adjunt for intra-operative pain relief.Methods: This cross-sectional survey was conducted for 3 months in a tertiary care university hospital in Karachi, Pakistan. All patients admitted for surgery and received IV paracetamol were enrolled. Data was collected by administering a pre-coded questionnaire to anesthetists about the patient and response to the IV paracetamol. Results: In total 270 patients were enrolled. Of all, most were young males (59%) with American Society of Anaesthesiology (ASA) II status. In addition to paracetamol, pethidine was most often used. There was a 94% satisfaction rate and most anesthetics felt that the cost was justified. Heart rate was the variable most affected (60%).Conclusion: Most anesthetists were satisfied with the use of IV paracetamol as an adjunct to intra-operative analgesia.
Intraoperative blood glucose levels in neurosurgical patients : an evaluation of two fluid regimens.
Swamy M,Murthy H,Rao G
Neurology India , 2001,
Abstract: Based on the evidence that hyperglycaemia aggravates ischaemic cerebral injury, it has been suggested that blood glucose levels be kept within 200 mg/dL during intracranial neurosurgery. Hypoglycaemia, however, can be a serious problem if glucose-containing solutions are avoided during the first four hours, as suggested in some studies. In order to explore the possibility of administering glucose in moderation so that the blood glucose levels are within acceptable limits, but at the same time the risk of hyoglycaemia is eliminated, we compared two intraoperative fluid regimens. Of the 52 neurosurgical patients studied, 32 patients received alternately 500 ml of 5% dextrose in normal saline and Ringer′s lactate (DNS/RL Group) and 18 patients received alternately 500 ml of Ringer′s lactate and normal saline (RL/NS Group). Blood glucose concentrations were determined at the end of each unit of fluid, until the patient received 4 units of fluid. In the DNS/RL group, blood glucose values peaked with the administration of each unit of DNS and tended to return towards the baseline with the subsequent RL, but remained higher than the previous control value. In the RL/NS group, there was a progressive increase in blood glucose values throughout the study period, but the increase was not statistically significant. The blood glucose levels were significantly different between the two groups after each unit of fluid except at the end of the fourth unit. Two patients in the RL/NS group had hypoglycaemia. In conclusion, the DNS/RL regimen maintains blood glucose levels within acceptable limits while avoiding the risk of hyperglycaemia. Withholding glucose completely, lowers blood glucose levels, but carries a risk of hypoglycaemia in some patients.
Comparison of Oral Paracetamol versus Ibuprofen in Premature Infants with Patent Ductus Arteriosus: A Randomized Controlled Trial  [PDF]
Dan Dang, Dongxuan Wang, Chuan Zhang, Wenli Zhou, Qi Zhou, Hui Wu
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0077888
Abstract: Trial Design Oral ibuprofen has demonstrated good effects on symptomatic patent ductus arteriosus (PDA) but with many contraindications and potential side-effects. In the past two years, oral paracetamol administration to several preterm infants with PDA has been reported. Here, a randomized, non-blinded, parallel-controlled and non-inferiority trial was designed to evaluate the efficacy and safety profiles of oral paracetamol to those of standard ibuprofen for PDA closure in premature infants. Methods One hundred and sixty infants (gestational age ≤34 weeks) with echocardiographically confirmed PDA were randomly assigned to receive either oral paracetamol (n = 80) or ibuprofen (n = 80). After the initial treatment course in both groups, the need for a second course was determined by echocardiographic evaluation. The main outcome was rate of ductal closure, and secondary outcomes were adverse effects and complications. Result The ductus was closed in 65 (81.2%) infants of the paracetamol group compared with 63 (78.8%) of the ibuprofen group. The 95% confidence interval of the difference between these groups was [?0.080,0.128], demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen. In fact, the incidence of hyperbilirubinemia or gastrointestinal bleeding in the paracetamol group was significantly lower than that of the ibuprofen group. No significant differences in other clinical side effects or complications were noted. Conclusion This comparison of drug efficacy and safety profiles in premature infants with PDA revealed that oral paracetamol was comparable to ibuprofen in terms of the rate of ductal closure and even showed a decreased risk of hyperbilirubinemia or gastrointestinal bleeding. Therefore, paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants. Trial Registration ChiCTR.org ChiCTR-TRC-12002177
Effects of Prophylactic and Therapeutic Paracetamol Treatment during Vaccination on Hepatitis B Antibody Levels in Adults: Two Open-Label, Randomized Controlled Trials  [PDF]
Anne M. C. M. Doedée, Greet J. Boland, Jeroen L. A. Pennings, Arja de Klerk, Guy A. M. Berbers, Fiona R. M. van der Klis, Hester E. de Melker, Henk van Loveren, Riny Janssen
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0098175
Abstract: Worldwide, paracetamol is administered as a remedy for complaints that occur after vaccination. Recently published results indicate that paracetamol inhibits the vaccination response in infants when given prior to vaccination. The goal of this study was to establish whether paracetamol exerts similar effects in young adults. In addition, the effect of timing of paracetamol intake was investigated. In two randomized, controlled, open-label studies 496 healthy young adults were randomly assigned to three groups. The study groups received paracetamol for 24 hours starting at the time of (prophylactic use) - or 6 hours after (therapeutic use) the primary (0 month) and first booster (1 month) hepatitis B vaccination. The control group received no paracetamol. None of the participants used paracetamol around the second booster (6 months) vaccination. Anti-HBs levels were measured prior to and one month after the second booster vaccination on ADVIA Centaur XP. One month after the second booster vaccination, the anti-HBs level in the prophylactic paracetamol group was significantly lower (p = 0.048) than the level in the control group (4257 mIU/mL vs. 5768 mIU/mL). The anti-HBs level in the therapeutic paracetamol group (4958 mIU/mL) was not different (p = 0.34) from the level in the control group. Only prophylactic paracetamol treatment, and not therapeutic treatment, during vaccination has a negative influence on the antibody concentration after hepatitis B vaccination in adults. These findings prompt to consider therapeutic instead of prophylactic treatment to ensure maximal vaccination efficacy and retain the possibility to treat pain and fever after vaccination. Trial Registration Controlled-Trials.com ISRCTN03576945
A randomized, double-blind, placebo-controlled trial of paracetamol and ketoprofren lysine salt for pain control in children with pharyngotonsillitis cared by family pediatricians
Nicolino Ruperto, Luigi Carozzino, Roberto Jamone, Federico Freschi, Gianfranco Picollo, Marcella Zera, Ornella Della Casa Alberighi, Enrica Salvatori, Alessandra Del Vecchio, Paolo Dionisio, Alberto Martini
Italian Journal of Pediatrics , 2011, DOI: 10.1186/1824-7288-37-48
Abstract: A double-blind, randomized, placebo-controlled trial of a 12 mg/kg single dose of paracetamol paralleled by open-label ketoprofren lysine salt sachet 40 mg. Six to 12 years old children with diagnosis of pharyngo-tonsillitis and a Children's Sore Throat Pain (CSTP) Thermometer score > 120 mm were enrolled. Primary endpoint was the Sum of Pain Intensity Differences (SPID) of the CSTP Intensity scale by the child.97 children were equally randomized to paracetamol, placebo or ketoprofen. Paracetamol was significantly more effective than placebo in the SPID of children and parents (P < 0.05) but not in the SPID reported by investigators, 1 hour after drug administration. Global evaluation of efficacy showed a statistically significant advantage of paracetamol over placebo after 1 hour either for children, parents or investigators. Patients treated in open fashion with ketoprofen lysine salt, showed similar improvement in pain over time. All treatments were well-tolerated.A single oral dose of paracetamol or ketoprofen lysine salt are safe and effective analgesic treatments for children with sore throat in daily pediatric ambulatory care.Treatment of acute pain, particularly in pediatric population, should be a priority for clinicians. In the past, pain has been underestimated and sometimes undertreated in children, probably due to individual and social attitudes toward pain and the complexity of its assessment in children [1-3]. Nowadays, the importance of pain control in the pediatric population is widely recognized. However, there is still a lack of adequate clinical trials assessing the pharmacological effects of the oral analgesics commonly used in pediatric daily primary care [3,4].Paracetamol (acetaminophen) is currently one of the most popular and widely used analgesic and antipyretic in children for the symptomatic treatment of acute pain and fever. Differently from non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol does not produce gastrointestinal dam
PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN 74418480]
Eric J van Breda, H Bart van der Worp, H Maarten A van Gemert, Ale Algra, L Jaap Kappelle, Jan van Gijn, Peter J Koudstaal, Diederik WJ Dippel, the PAIS investigators
BMC Cardiovascular Disorders , 2005, DOI: 10.1186/1471-2261-5-24
Abstract: Paracetamol (Acetaminophen) In Stroke (PAIS) is a randomized, double-blind clinical trial, comparing high-dose acetaminophen with placebo in 2500 patients. Inclusion criteria are a clinical diagnosis of hemorrhagic or ischemic stroke and the possibility to start treatment within 12 hours from onset of symptoms. The study will have a power of 86% to detect an absolute difference of 6% in the risk of death or dependency at three months, and a power of 72% to detect an absolute difference of 5%, at a 5% significance level.This is a simple trial, with a drug that only has a small effect on body temperature in normothermic patients. However, when lowering body temperature with acetaminophen does have the expected effectiveness, 20 patients will have to be treated to prevent dependency or death in one.In patients with acute stroke, increased body temperature is associated with high case fatality and poor functional outcome [1]. In the observational Copenhagen Stroke study, a 1°C increase in body temperature measured within 12 hours after stroke onset doubled the odds of poor outcome. The relation between body temperature and outcome was not affected by severity of symptoms at admission, lesion volume, or stroke type [1-6]. This suggests that even a small reduction in body temperature in acute stroke could improve outcome.We conducted two randomized, placebo-controlled clinical trials to study whether early treatment with acetaminophen reduces body temperature in patients with acute ischemic stroke confined to the carotid territory. In the first trial, seventy-six patients were randomized to daily treatment with either 3000 or 6000 mg acetaminophen, or placebo. In the high-dose group this resulted in a 0.4°C (95% CI: 0.1 to 0.7°C) lower body temperature than placebo treatment at 24 hours after onset [7]. The second trial was conducted to study the effect of ibuprofen and to confirm the effect of high-dose acetaminophen on body temperature. Seventy-five patients with acute
Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480]
Heleen M den Hertog, H Bart Worp, H Maarten A van Gemert, Ale Algra, L Jaap Kappelle, Jan van Gijn, Peter J Koudstaal, Diederik WJ Dippel, the PAIS investigators
BMC Cardiovascular Disorders , 2008, DOI: 10.1186/1471-2261-8-29
Abstract: The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS) may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis.Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial.The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power.Current Controlled Trials [ISCRTN74418480]The Paracetamol (Acetaminophen) In Stroke (PAIS) Study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved long-term functional outcome through a modest reduction in body temperature and prevention of fever [1].In the original protocol, the primary outcome measure is a dichotomized score on the modified Rankin Scale (mRS) [2] assessed at 3 months from onset of symptoms, with good functional outcome defined as a score of 0–2 and poor functional outcome as a score of 3-death.The common approach of dichotomizing the mRS, an ordinal outcome scale, has several disadvantages. First, it may not correspond with everyday clinical practice. Dichotomized outcome analyses convert ordinal scales into binary outcome measures. Most treatment strategies tested in acute stroke trials are not expected to be completely curative, but to lead to improvement. Therefore, it is also informative to show that treatment moves patients from severe to m
Intraoperative Maintenance of Normoglycemia with Insulin and Glucose Preserves Verbal Learning after Cardiac Surgery  [PDF]
Thomas Schricker, Hiroaki Sato, Thomas Beaudry, Takumi Codere, Roupen Hatzakorzian, Jens C. Pruessner
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0099661
Abstract: Objective The hyperglycemic response to surgery may be a risk factor for cognitive dysfunction. We hypothesize that strict maintenance of normoglycemia during cardiac surgery preserves postoperative cognitive function. Methods As part of a larger randomized, single-blind, interventional efficacy study on the effects of hyperinsulinemic glucose control in cardiac surgery (NCT00524472), consenting patients were randomly assigned to receive combined administration of insulin and glucose, titrated to preserve normoglycemia (3.5–6.1 mmol L?1; experimental group), or standard metabolic care (blood glucose 3.5–10 mmol L?1; control group), during open heart surgery. The patients’ cognitive function was assessed during three home visits, approximately two weeks before the operation, and two months and seven months after surgery. The following tests were performed: Rey Auditory Verbal Learning Task (RAVLT for verbal learning and memory), Digit Span Task (working memory), Trail Making A & B (visuomotor tracking and attention), and the Word Pair Task (implicit memory). Questionnaires measuring specific traits known to affect cognitive performance, such as self-esteem, depression, chronic stress and social support, were also administered. The primary outcome was to assess the effect of hyperinsulinemic-normoglycemic clamp therapy versus standard therapy on specific cognitive parameters in patients receiving normoglycemic clamp, or standard metabolic care. Results Twenty-six patients completed the study with 14 patients in the normoglycemia and 12 patients in the control group. Multiple analysis of covariance (MANCOVA) for the RAVLT showed a significant effect for the interaction of group by visit (F = 4.07, p = 0.035), and group by visit by recall (F = 2.21, p = 0.04). The differences occurred at the second and third visit. MANCOVA for the digit span task, trail making and word pair association test showed no significant effect. Conclusions Preserving intraoperative normoglycemia by intravenous insulin and glucose may prevent the impairment of memory function, both short and long-term, after cardiac surgery.
Effect of Intraoperative High-Dose Remifentanil on Postoperative Pain: A Prospective, Double Blind, Randomized Clinical Trial  [PDF]
Yan-Ling Zhang, Peng Ou, Xiang-Hang Lu, Yan-Ping Chen, Jun-Mei Xu, Ru-Ping Dai
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0091454
Abstract: Background Remifentanil, an ultra-short-acting opioid, is widely used for pain control during surgery. However, regular dose (RD) remifentanil exacerbates postoperative pain in a dose-dependent manner. Recent studies suggest that high-dose (HD) remifentanil offers sustained analgesia in experimental studies. We thus hypothesized that intraoperative administration of high-dose remifentanil may attenuate postoperative pain. Methods In this prospective, randomized, double blind, controlled clinical study, sixty patients undergoing thyroidectomy (18–60 years-of-age) received an intraoperative infusion of 0.2 (RD group) or 1.2 μg kg?1min?1 (HD group) remifentanil during thyroidectomy. A visual analogue scale (VAS) was used to measure pain intensity. Mechanical pain threshold on the forearm was assessed using von Frey filaments before surgery (baseline), 2 h postoperatively and 18–24 h postoperatively. The primary outcome was to compare the difference of VAS score at different time points after operation and morphine consumption 24 h postoperatively between RD and HD groups. The second outcome was to compare the difference of mechanical pain thresholds in the forearm postoperatively between RD and the HD groups. Results VAS scores were lower 30 min postoperatively in the HD group (1.29±1.67, 95% CI 0.64–1.94) compared with the RD group (2.21±1.67, 95% CI 1.57–2.84) (t = 3.427, p = 0.0043, RD group vs. HD group). Postoperative morphine consumption was much lower in the HD group compared with the RD group (1.27±1.88 mg vs. 0.35±1.25 mg, p = 0.033). In both groups, mechanical pain threshold was decreased 18–24 h postoperatively (2.93±0.209 Ln(g) vs. 3.454±2.072 Ln(g), p = 0.032 in RD group; 2.910±0.196 Ln(g) vs. 3.621±0.198 Ln(g), p = 0.006 in HD group, 18–24 h postoperatively vs baseline). Conclusions Intraoperative administration of high-dose remifentanil decreased VAS scores and morphine consumption postoperatively. Thus, modulation of intraoperative opiates may be a simple and effective method of postoperative pain management. Trial Registration This trial is registered in ClinicalTrials.gov, with the Name: Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy, and ID number: NCT01761149.
Effects of Aerobic Exercise and Whole Body Vibration on Glycaemia Control in Type 2 Diabetic Males  [cached]
Lale Behboudi,Mohammad-Ali Azarbayjani,Hamid Aghaalinejad,Mahyar Salavati
Asian journal of Sports Medicine , 2011,
Abstract: Purpose:Aerobic exercise has been identified as the main treatment for type 2 diabetic patients. Such an exercise, however, is usually repined by some of patients who suffer from lack of stamina. Therefore, whole body vibration has recently been introduced as a passive intervention. The present study aimed at comparing how aerobic exercise and whole body vibration affect glycaemia control in type 2 diabetic males.Methods:Thirty diabetic males were divided into three groups, namely aerobic exercise (AE), whole body vibration (WBV), and control. Aerobic exercise schedule consisted of three walking sessions a week, each for 30-60 minutes and in 60-70% of maximum stock heartbeat. Vibration exercise was composed of 8-12-min stand-up and semi-squat positioning in frequency of 30 Hz and amplitude of 2 mm. Concentrations of fasting glycosylated hemoglobin, fasting glucose, and insulin were measured in the beginning of the trial, after the fourth week, and after the eighth week.Results:After 8 weeks of exercise, no significant difference was detected in concentrations of fasting glycosylated hemoglobin and insulin between the groups (P=0.8, P=0.1). There were no significant differences in any of the variables between AE and WBV (P>0.05). But a more significant decrease in fasting glucose was observed in exercise groups (AE and WBV) compared with control group (P=0.02).Conclusions:The present study showed that AE and WBV identically stimulate metabolic system. Thus, it can be concluded that type 2 diabetic patients lacking stamina for aerobic exercise can opt for vibration exercise as an effective substitute.
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