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Six randomized, double-blind, two-period crossover studies, conducted under similar protocols, compared the efficacy of two analgesic combinations containing caffeine with an acetaminophen 1000 mg control and with a placebo in outpatients with episodic tension-type headaches. In four studies, comprising 1900 patients, the caffeine-containing analgesic consisted of a combination of 500 mg acetaminophen, 500 mg aspirin, and 130 mg caffeine (APAP/ASA/CAF). In two studies, comprising 911 patients, the caffeine-containing analgesic consisted of a combination of 1000 mg acetaminophen and 130 mg caffeine (APAP/CAF). Patients self-medicated for moderate or severe headache pain, and with a self-rating record they rated their pain and its relief hourly for 4 hours. In all six studies, the caffeine-containing analgesics were significantly superior both to placebo and to 1000 mg acetaminophen, and acetaminophen was significantly superior to placebo. The significant analgesic adjuvant effect of caffeine was independent of patients' usual caffeine use or their caffeine consumption in the 4 hours before medication. For each treatment, the pooled analgesic responses for the four studies of APAP/ASA/CAF were virtually superimposable on the responses in the two APAP/CAF studies. The combinations produced more stomach discomfort, nervousness, and dizziness than acetaminophen or placebo.
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PMID:Caffeine as an analgesic adjuvant in tension headache. 795 22

Sevoflurane is a "new" volatile inhaled anaesthetic that is currently undergoing phase III clinical trial in Europe and the United States. Owing to the low blood solubility, rapid induction of anaesthesia and emergence from anaesthesia would be expected. In this study, we compared emergence times and haemodynamics in patients receiving either sevoflurane or isoflurane. Furthermore, all adverse effects were recorded and the relationship to the drug administered was rated. METHODS. Fifty ASA physical status I and II patients were studied in an open, prospective, randomised clinical trial. Anaesthesia was induced with fentanyl, thiopentone, and vecuronium for facilitating endotracheal intubation and maintained with sevoflurane or isoflurane, 60% nitrous oxide (N2O) in oxygen (O2), and additional doses of fentanyl (1-2 micrograms/kg.h). The electrocardiogram, blood pressure (non-invasive), O2 saturation, temperature, and end-tidal concentrations of sevoflurane or isoflurane, N2O, and carbon dioxide were monitored continuously. At the end of surgery, administration of sevoflurane or isoflurane and N2O was discontinued without tapering and emergence times were recorded. All adverse events that occurred until the 3rd postoperative day were recorded and the relationship to the inhaled anaesthetic was rated as "none", "unlikely", "possible", "probable", or "highly probable". RESULTS. With the exception of gender, the two patient groups were comparable (Tables 1 and 2). Due to the higher MAC value, mean end-tidal concentrations were higher for sevoflurane (0.82% vs. 0.59% for isoflurane). The duration of anaesthetic exposure was 1.3 MAC h (calculation with FIO2 = 1.0 MAC value) and 3.1 MAC h (calculation with FIO2 = 0.4 in N2O MAC value), respectively, for both inhaled anaesthetics. Pulmonary elimination was faster (Fig. 1) and emergence time shorter (7 min vs. 11.5 min, Table 3) with sevoflurane. There was no difference in the time courses of heart rate and mean arterial blood pressure (Figs. 2 and 3). No adverse effects with a "probable" or "highly probable" relationship to the inhaled anaesthetic were observed. Table 4 shows the adverse events with a possible relationship to the drug administered. Further evaluations of nausea, vomiting, and dizziness are shown in Table 5. DISCUSSION. Emergence time after inhalation anaesthesia depends on pulmonary elimination and MACawake, that is, the end-tidal concentration that would allow opening of the eyes on verbal command. Pulmonary elimination depends on dose applied (MAC h), alveolar ventilation, and blood-gas solubility coefficient. Due to the lower blood-gas solubility coefficient (0.6-0.7 for sevoflurane vs. 1.3-1.4 for isoflurane) and in accordance with the investigations of Frink et al. [4] and Smith et al. [16], emergence time was significantly shorter with sevoflurane. Gender, the only difference between the two patient groups, does not influence pulmonary elimination and MACawake [8]. Supplementing inhalation anaesthesia with fentanyl, there was no difference in the time courses of heart rate and mean arterial blood pressure between sevoflurane and isoflurane. Adverse events with a possible relationship to the inhaled anaesthetic occurred in both groups.
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PMID:[Emergence times, hemodynamics and adverse effects of sevoflurane and isoflurane: an open, randomized, comparative phase iii study]. 797 85

Sevoflurane was compared with isoflurane in 246 adult ASA class I-III patients undergoing ambulatory surgery. After administration of midazolam 1-2 mg and fentanyl 1 microgram/kg, anesthesia was induced with propofol 2 mg/kg and maintained with either sevoflurane or isoflurane in 60% nitrous oxide to maintain arterial blood pressure at +/- 20% of baseline. Fresh gas flows were 10 L/min during induction and 5 L/min during maintenance. Times to eye opening, command response, orientation, and ability to sit without nausea and/or dizziness were significantly faster after sevoflurane. Significantly more sevoflurane patients met Phase 1 of postanesthesia care unit (PACU) Aldrete recovery criteria (> or = 8) at arrival, 95% vs 81%. Also, significantly more sevoflurane patients were able to complete psychomotor recovery tests during the first 60 min postanesthesia. Discharge times were not different. Sevoflurane patients had significantly lower incidences of postoperative somnolence (15% vs 26%) and of nausea both in the PACU (36% vs 51%) and in the 24-h postdischarge period (9% vs 24%). Patient satisfaction was high overall (sevoflurane 97%, isoflurane 93%). We conclude that sevoflurane is a useful inhaled anesthetic for maintenance of ambulatory anesthesia.
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PMID:A multicenter comparison of maintenance and recovery with sevoflurane or isoflurane for adult ambulatory anesthesia. The Sevoflurane Multicenter Ambulatory Group. 869 11

This study was designed to assess the efficacy of oral transmucosal fentanyl citrate (OTFC) for premedication in an adult population and to determine its effects on anxiety, sedation, gastric volume, and gastric fluid acidity. The fentanyl citrate is incorporated in a lozenge mounted on a handle (oralet). The effects of OTFC, placebo oralet, and no premedication were compared in a prospective, double-blind study on 90 adult ASA physical status I and II patients undergoing same-day admission surgery. Patients were randomly assigned to one of three groups: OTFC group (n = 30), placebo group (n = 30), and control group (n = 30). Arterial blood pressure, heart rate, respiratory frequency, and oxygen saturation determined by pulse oximetry were recorded before any premedication was given, and then every 10 min until the patient was taken to the operating room. Baseline anxiety and sedation levels were assessed to ensure group similarity immediately before premedication was given and at the more anxiety-provoking phase upon entering the operating room. Anxiety levels were rated using the Spielberger State-Trait Anxiety Inventory short form and sedation levels were assessed with the Ramsay scale. Side effects, as reported by the patients, were also recorded. Gastric contents were aspirated via an orogastric tube after induction of anesthesia and were measured for volume and pH. No significant differences were found among the three groups in mean arterial pressure, heart rate, or respiratory frequency. Initial oxygen saturation levels in all groups decreased after 30 min but not less than 96% except for one patient in the OTFC group, who decreased to 88%. On entering the operating room, the OTFC group demonstrated significantly higher levels of anxiolysis than the control group, but no significant differences were seen between the OTFC and the placebo groups or the placebo and control groups. Mean gastric volumes (OTFC, 29 mL; placebo, 26 mL; control, 24 mL) and pH (OTFC, 2.0; placebo, 1.8; control, 2.1) were similar in all groups. There were no significant differences among the groups in levels of sedation achieved. Mild dizziness or light-headedness was the most commonly reported side effect in 23% of the OTFC group. In the OTFC group, 71.4% like the premedicant effect as compared to 46.4% of the placebo group. Most of the groups found the oralet method of premedicant delivery very acceptable. This study demonstrates that the OTFC oralet is an effective anxiolytic in adults. It has minimal side effects and is prepared in an acceptable format. There was no measurable increase in gastric contents or acidity in the oralet groups, compared to those patients who were given nothing by mouth.
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PMID:Oral transmucosal fentanyl citrate for premedication in adults. 871 94

Fifty patients undergoing colonic surgery received combined thoracic epidural and general anesthesia followed by continuous epidural bupivacaine 0.25% and morphine 0.05 mg/mL, 4 mL/h, for 96 h postoperatively plus oral tenoxicam 20 mg daily. Heart rate (HR) and arterial blood pressure (BP) were measured at supine rest, during orthostatic stress, and after walking prior to and 24, 48, and 72 h and 48 h postoperatively compared to preoperatively (P < or = 0.008); 16 vs 6 patients presented resting systolic BP values < 100 mm Hg (lower range, 70 mm Hg) post- versus preoperatively (P = 0.048). During orthostatic stress the decrease in systolic BP and concomitant increase in HR was similar post- versus preoperatively (BP, P > 0.3; HR, P > 0.34) and 12 vs 8 patient; (P = 0.45) experienced a systolic BP decrease > 20 mm Hg post- versus preoperatively. After walking, systolic BP was significantly lower postoperatively compared with preoperatively (P < or = 0.01). Epidural infusion was discontinued in three patients due to either persisting resting or orthostatic hypotension. There was no correlation between ASA classification, intraoperative bleeding, or postoperative dizziness and incidence of orthostatic hypotension. The results suggest that patients undergoing abdominal surgery and treated with continuous small-dose thoracic epidural bupivacaine-morphine are subjected to a decrease of BP at rest and during mobilization, but not to an extent that seriously impairs ambulation in most patients.
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PMID:Orthostatic hypotension during postoperative continuous thoracic epidural bupivacaine-morphine in patients undergoing abdominal surgery. 889 80

Thirty-eight ASA I-III patients undergoing lower abdominal operations were randomly allocated to receive either morphine (group M, patient-controlled analgesia bolus = 1 mg of morphine) or tramadol (group T, patient-controlled analgesia bolus = 10 mg of tramadol) for post-operative patient-controlled analgesia (PCA) after receiving morphine intraoperatively. There were no between-group differences in the pain, sedation or vomit scores. The nausea scores were significantly higher in group T in the initial 20 h and between 32 and 36 h (P < 0.01, 0-4 and 8-12 h; P < 0.05, 4-8, 12-16, 16-20 and 32-36 h). The incidence of dizziness was also significantly higher in group T (68.4% vs. 31.6%, group T vs. group M, P < 0.05). There was no difference in the overall satisfaction. We conclude that the use of tramadol, compared with morphine, for post-operative PCA after intraoperative loading with morphine is associated with more nausea and dizziness, but with similar sedation, quality of analgesia and patient satisfaction.
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PMID:Increased nausea and dizziness when using tramadol for post-operative patient-controlled analgesia (PCA) compared with morphine after intraoperative loading with morphine. 978 72

The success of out-patients laparoscopic surgery depends on a careful selection of patients and the ability of anesthetic technique to ensure a rapid emergence from anesthesia, with a satisfactory control of postoperative pain and the absence of side effects. This study was undertaken to investigate the influence of a total intravenous anesthetic management on the recovery process after laparoscopic varicocelectomy. Fifty-three ASA 1 patients aged 12-41 yrs (mean 26.02) scheduled to undergo laparoscopic varicocelectomy as day surgery procedure were included in this study. Propofol was used as inductor agent and in variable-rate infusion (170-100 mcg/Kg/min) to maintain anesthesia supplemented with Fentanyl (FNT) before endotracheal intubation, incision surgery and if the patient manifested clinical signs of inadequate analgesia. Local anesthesia was infiltrated into the skin before incision. Tramadol 100 mg and Ketorolac 30 mg were administered before the end of surgery to delay the onset of the postoperative pain. Pain was evaluated using a self-rating visual analoque scale (VAS) ranging from 0 to 10 at 0-0.5 hrs postoperatively and every 2 hrs until discharge. At the same time nausea was clinically evaluated using a scale ranging from 0 to 3. Postoperative pain and nausea (PONV) treatment were standardized. Patients were discharged by Post-Anesthesia Discharge Scoring System (PADS). Mean operating time was 34.2 min and mean estubation time was 11.6 min. At time 0 all patients had VAS pain score < 3, on the same time 2 of patients was treated for mild PONV; mean time to first request for postoperative analgesia treatment in 89% of patients was more than 6 hrs, 5 patients required pain treatment before discharge in a mean time 216' +/- 156'. Using the PADS system, 64% of patients were discharged at 4 hrs and 89% at 6 hrs after surgery. One patient was admitted to hospital for an overnight stay for walking dizziness; another was readmitted for surgical complications. This results suggest that the proposed anesthetic management provided adequate pain control with minimun postoperative nausea and a good recovery rate. This permitted a short postoperative hospital stay without compromising in safety, efficacy, or patient satisfaction.
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PMID:[Laparoscopic surgery of varicocele. Role of total endovenous anesthesia in same-day discharge]. 1112 41

We compared in a prospective, randomized, double-blinded study the analgesic efficacy of three drugs in 120 ASA I and II patients scheduled to undergo ambulatory hand surgery with IV regional anesthesia. At discharge, oral analgesic tablets were prescribed as follows: tramadol 100 mg every 6 h, metamizol 1 g every 6 h, and paracetamol (acetaminophen) 1 g every 6 h. Rescue medication consisted of oral dextropropoxyphene 100 mg on demand. Analgesic efficacy was evaluated by self-assessment of pain intensity by visual analog score at six different time intervals during the 48-h study period. Patients also recorded global pain relief on a 5-grade scale, total number of study and rescue analgesic tablets, frequency and severity of adverse effects, sleep pattern, and overall satisfaction. None of the study drugs alone provided effective analgesia in all patients. The percentage of patients who required supplementary analgesics was 23% with tramadol, 31% with metamizol, and 42% with acetaminophen. Tramadol was the most effective analgesic, as evidenced by low pain scores, least rescue medication, and fewest number of patients with sleep disturbance. However, the incidence of side effects was also increased with tramadol. Seven patients (17.5%) withdrew from the study because of the severity of nausea and dizziness associated with the use of tramadol. Metamizol and acetaminophen provided good analgesia in about 70% and 60% of patients, respectively, with a decreased incidence of side effects. Despite receiving oral analgesic medication, up to 40% of patients undergoing hand surgery experienced inadequate analgesia in this controlled trial. Although tramadol was more effective, its use was associated with the highest frequency and intensity of adverse effects and the most patient dissatisfaction. Metamizol and acetaminophen provided good analgesia with a small incidence of side effects. For patients undergoing ambulatory hand surgery, postoperative pain can last longer than 2-3 days, and there is a need for both better education before the procedure and oral analgesic therapy at home.
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PMID:Postoperative analgesia at home after ambulatory hand surgery: a controlled comparison of tramadol, metamizol, and paracetamol. 1115 30

Single-shot "kiddie caudal" with bupivacaine alone is losing popularity because of its duration of 4-8 h. In a prospective randomized double-blind clinical study, we assessed and compared the efficacy of ketamine, midazolam, and neostigmine coadministered with bupivacaine in a caudal epidural to provide intraoperative and postoperative pain relief. Eighty children (ASA status I) aged 5-10 yr undergoing unilateral inguinal herniotomy were allocated randomly in equal numbers (n = 20) into 4 groups to receive a caudal injection of 0.25% bupivacaine (1 mL/kg) with or without ketamine (0.5 mg/kg), midazolam (50 microg/kg), and neostig-mine (2 microg/kg), after the induction of standardized general anesthesia without premedication. Monitoring for pain, sedation, postoperative nausea/vomiting, dizziness, and pruritus was performed by anesthesiologists blinded to the study allocation. The time to first analgesic administration (paracetamol syrup) was longer (P < 0.05) in the bupivacaine-neostigmine group and the bupivacaine-midazolam group than in the other groups. Undesirable effects, such as emesis, pruritus, and dizziness, were comparable in all groups. However, the incidence of hallucination was more frequent in the bupivacaine-ketamine group compared with the other groups. This study shows that single-shot caudal coadministration of bupivacaine-neostigmine and bupivacaine-midazolam was associated with an extended duration of postoperative pain relief.
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PMID:Caudal additives in pediatrics: a comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. 1652

A 91-yr-old man (57 kg, 156 cm, ASA III) received an infraclavicular brachial plexus block for surgery of bursitis of the olecranon. Twenty minutes after infraclavicular injection of 30 mL of mepivacaine 1% (Scandicain) and 5 min after supplementation of 10 mL of prilocaine 1% (Xylonest) using an axillary approach, the patient complained of agitation and dizziness and became unresponsive to verbal commands. In addition, supraventricular extrasystole with bigeminy occurred. Local anesthetic toxicity was suspected and a dose of 200 mL of a 20% lipid emulsion was infused. Symptoms of central nervous system and cardiac toxicity disappeared within 5 and 15 min after the first lipid injection, respectively. Plasma concentrations of local anesthetics were determined before, 20, and 40 min after lipid infusion and were 4.08, 2.30, and 1.73 microg/mL for mepivacaine and 0.92, 0.35, and 0.24 microg/mL for prilocaine. These concentrations are below previously reported thresholds of toxicity above 5 microg/mL for both local anesthetics. Signs of toxicity resolved and the patient underwent the scheduled surgical procedure uneventfully under brachial plexus blockade.
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PMID:Reversal of central nervous system and cardiac toxicity after local anesthetic intoxication by lipid emulsion injection. 1842 Aug 41


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