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Efficacy and safety of a PCA protocol, without loading dose or background infusion, was investigated in 40 consenting patients after osteotomy of the foot. All patients had intrathecal lidocaine 5% 1.8 ml preoperatively. Postoperative pain relief was provided with morphine from a Baxter Travenol infusor with PC module. The morphine concentration was 2 mg/ml or 3 mg/ml. In order to reach the analgesic blood concentration as quickly as possible, the patients were instructed to start PCA from the very first moment pain occurred. The patients breathed room air. The nursing staff evaluated respiratory and cardiovascular parameters, pain and side effects. Although mean VAS scores were higher than 3 in the early postoperative phase, no supplementary analgesics were required. One patient had urine retention. One patient had a drop in blood pressure at the start of morphine, which was quickly restored with the administration of colloids. Oxygen saturations were lower (SpO2 < 95%) the first hours postoperatively, especially at the first assessment where no morphine was administered. Pain or relative hypovolaemia could be an explanation. Dry mouth and sleepiness were the most frequently reported side-effects, followed by dizziness, vomiting and nausea. Sweating and itching were less frequently reported. The occurrence of the side effects was the highest during the first postoperative day. We conclude that even when morphine is used in PCA without loading dose or background infusion after opiate-free locoregional analgesia, close monitoring is necessary for at least 5 hours.
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PMID:Evaluation of morphine for patient controlled analgesia with the Infusor system after opiate-free locoregional anesthesia for osteotomy of the foot. 866 16

Adequate postoperative analgesia without side effects is necessary to facilitate same-day discharge of ambulatory patients after ambulatory surgery. This study compared the use of intravenous morphine and fentanyl after painful ambulatory procedures with respect to analgesic efficacy, the incidence of side effects, and impact on the patient's readiness for discharge. Fifty-eight patients undergoing ambulatory surgery were prospectively randomized to receive morphine or fentanyl for postoperative analgesia and studied in double-blind fashion. The drugs were administered in equipotent doses in the postanesthesia care unit (PACU) and were titrated against pain scores until a visual analog score < 40 mm was achieved and the patient was satisfied with the level of analgesia. In the ambulatory surgical unit, oral analgesia was available. Pain scores, amount of analgesia used, the incidence of side-effects (nausea and vomiting, sedation and dizziness), the times to achieve recovery milestones, and fitness for discharge were studied. Equal amounts of morphine and fentanyl were used in the PACU, but pain scores were higher in the fentanyl group in the ambulatory surgical unit. In addition, the fentanyl group required more oral analgesia than the morphine group (69% vs 17%; P < 0.0002). The incidence of in-hospital side effects was similar. However, the morphine group had a more frequent incidence of postdischarge nausea and vomiting than the fentanyl group (59% vs 24%; P < 0.016). There was no significant difference in the duration of stay in the PACU (morphine vs fentanyl, 69 +/- 15 min vs 71 +/- 20 min), the times to achieve recovery milestones, and fitness for discharge (morphine vs fentanyl, 136 +/- 41 min vs 132 +/- 40 min). The short duration of fentanyl was not associated with faster discharge times; most patients required additional analgesia to control pain. Morphine produced a better quality of analgesia but was associated with an increased incidence of nausea and vomiting, the majority of which occurred after discharge.
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PMID:Evaluation of morphine versus fentanyl for postoperative analgesia after ambulatory surgical procedures. 905 92

The pharmacology, pharmacokinetics, efficacy, adverse effects, and dosage and administration of tramadol are reviewed. Tramadol is a synthetic analogue of codeine that binds to mu opiate receptors and inhibits norepinephrine and serotonin reuptake. It is rapidly and extensively absorbed after oral doses and is metabolized in the liver. Analgesia begins within one hour and starts to peak in two hours. In patients with moderate postoperative pain, i.v. or i.m. tramadol is roughly equal in efficacy to meperidine or morphine; for severe acute pain, tramadol is less effective than morphine. Oral tramadol can also be effective after certain types of surgery. Tramadol and meperidine are equally effective in postoperative patient-controlled analgesia. In epidural administration for pain after abdominal surgery, tramadol is more effective than bupivacaine but less effective than morphine. In patients with ureteral calculi, both dipyrone and butylscopolamine are more effective than tramadol. For labor pain, i.m. tramadol works as well as meperidine and is less likely to cause neonatal respiratory depression. Oral tramadol is as effective as codeine for acute dental pain. In several types of severe or refractory cancer pain, tramadol is effective, but less so than morphine; for other types of chronic pain, such as low-back pain, oral tramadol works as well as acetaminophen-codeine. Common adverse effects of tramadol include dizziness, nausea, dry mouth, and sedation. The abuse potential seems low. The recommended oral dosage is 50-100 mg every four to six hours. Tramadol is an effective, if expensive, alternative to other analgesics in some clinical situations.
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PMID:Tramadol: a new centrally acting analgesic. 907 93

The analgesic effectiveness and safety of oral tramadol were compared with standard analgesics using a meta-analysis of individual patient data from randomised controlled trials in patients with moderate or severe pain after surgery or dental extraction. Calculation of %maxTOTPAR from individual patient data, and the use of > 50%maxTOTPAR defined clinically acceptable pain relief. Number-needed-to-treat (NNT) for one patient to have > 50%maxTOTPAR compared with placebo was used to examine the effectiveness of different single oral doses of tramadol and comparator drugs. Eighteen randomised, double-blind, parallel-group single-dose trials with 3453 patients using categorical pain relief scales allowed the calculation of %maxTOTPAR. The use of > 50%maxTOTPAR was a sensitive measure to discriminate between analgesics. Tramadol and comparator drugs gave significantly more analgesia than placebo. In postsurgical pain tramadol 50, 100 and 150 mg had NNTs for > 50%maxTOTPAR of 7.1 (95% confidence intervals 4.6-18), 4.8 (3.4-8.2) and 2.4 (2.0-3.1), comparable with aspirin 650 mg plus codeine 60 mg (NNT 3.6 (2.5-6.3)) and acetaminophen 650 mg plus propoxyphene 100 mg (NNT 4.0 (3.0-5.7)). With the same dose of drug postsurgical patients had more pain relief than those having dental surgery. Tramadol showed a dose-response for analgesia in both postsurgical and dental pain patients. With the same dose of drug postsurgical pain patients had fewer adverse events than those having dental surgery. Adverse events (headache, nausea, vomiting, dizziness, somnolence) with tramadol 50 mg and 100 mg had a similar incidence to comparator drugs. There was a dose response with tramadol, tending towards higher incidences at higher doses. Single-patient meta-analysis using more than half pain relief provides a sensitive description of the analgesic properties of a drug, and NNT calculations allow comparisons to be made with standard analgesics. Absolute ranking of analgesic performance should be done separately for postsurgical and dental pain.
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PMID:Single-patient data meta-analysis of 3453 postoperative patients: oral tramadol versus placebo, codeine and combination analgesics. 908 3

Fifty-nine patients underwent consecutive colonoscopic examination with premedication of electroacupuncture analgesia (EA) were compared with conventional meperidine analgesia (MA) in pain relief and changes of neurotransmitters in serum. The results showed that analgesic efficacy of both groups were the same but with less side effects in the EA group (P < 0.01) especially in regard to dizziness. Serum concentration of beta-endorphin in both groups has a similar curve change at 4 different phases during colonoscopy. Serum concentration of epinephrine, norepinephrine, dopamine and cortisol showed no significant difference between these two groups. The analgesic effect of EA and MA during colonoscopic examination may be closely related to beta-endorphin production in serum.
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PMID:A clinical study on physiological response in electroacupuncture analgesia and meperidine analgesia for colonoscopy. 916 93

Tramadol has been in clinical use in Germany since the late 1970s and has proven effective in both experimental and clinical pain without causing serious cardiovascular or respiratory side effects. Moreover, the negligible abuse potential of tramadol has meant that it has never been a restricted drug, and it therefore very quickly became the most popular analgesic of its class in Germany. Although tramadol has been used in myocardial emergencies, in trauma and obstetric pain, or to supplement balanced anaesthesia, most studies have investigated postoperative patients. The focus of this article is to review clinical experience with tramadol in the treatment of acute postoperative pain. Tramadol, a synthetic opioid of the aminocyclohexanol group, is a centrally acting analgesic with weak opioid agonist properties, and effects on noradrenergic and serotonergic neurotransmission. In addition, these opioid and nonopioid modes of action appear to act synergistically. Tramadol has been shown to provide effective analgesia after both intramuscular and intravenous administration for the treatment of postoperative pain. The drug is available in formulations suitable for oral, rectal and parenteral administration. Clinically effective analgesic doses of tramadol were comparable to those of pethidine (meperidine) and about 10 times higher than those of morphine. While it is not recommended as a supplement to general anaesthesia because of its insufficient sedative activity, tramadol has been successful in the treatment of postoperative pain. A randomised double-blind study reported acceptable analgesia with postoperative intravenous tramadol 50mg, repeated once if required after 30 minutes. It produced an effect similar to that of morphine 5mg or the alpha 2 agonist, clonidine 150 micrograms. In another study, it was shown that the 50mg dose of tramadol fulfilled the requirements of an analgesic for the treatment of moderate postoperative pain, whereas for severe pain a higher dose was recommended. Tramadol is generally well tolerated, the most common adverse events being nausea and vomiting. In contrast to agents such as morphine and pethidine, clinically relevant respiratory depression is rarely observed during tramadol administration at equipotent doses and consequently it can be recommended for first-line management of postoperative pain instead of morphine. It is also associated with a low incidence of cardiac depression and significantly less dizziness and drowsiness than morphine. Finally, the dependence and abuse potential with tramadol is negligible. Comparative studies have generally shown that tramadol is more effective than NSAIDs for controlling post operative pain. Use of a combination of tramadol and NSAIDs allows the tramadol dose to be reduced and results in a lower incidence of adverse effects. Patient controlled analgesia (PCA) with tramadol has been frequently used and is well accepted by patients. Wide individual variations exist with regard to analgesic requirements and, nowadays, it is generally accepted that adequate pain management implies systematic individualisation of the therapy, i.e. titration of the analgesic effect to individual needs. Demand and loading doses play a decisive role in the success of PCA. Analgesic failures requiring rescue medication are rare, but it should be stressed that these can always occur with weak opioids. In conclusion, tramadol can be recommended as a basic analgesic for the treatment of moderate to severe pain. In the event of analgesic failure with tramadol, there is no reason not to switch to more potent opioids. Although no studies are available regarding its use in the management of postoperative pain after day case surgery, tramadol is frequently administered with good results in such patients. The most important side effects of tramadol are nausea and emesis, which can often be prevented by slow injection and administration of a prophylactic antiemetic such as metoclopramid
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PMID:[Tramadol in acute pain]. 919 Mar 22

This article presents a summary of drug safety data concerning the use of tramadol hydrochloride and an outline of the specific aspects of this analgesic in particular with regard to respiratory depression and dependence potential. Information from phase II to IV clinical studies, postmarketing surveillance studies (covering safety data from a total of more than 21,000 patients) and the spontaneous reporting system have been taken into consideration. The data from the spontaneous reporting system covers the period between 1977 and 1993, during which more than one billion single dose units were distributed throughout the world. The phase II to IV studies compare acute intravenous, acute intramuscular, acute oral and multiple dose oral administration Postmarketing surveillance studies provide a picture of everyday use of tramadol in general medical practice. Further analyses were performed to provide information about the gender-, age- and dose-related distribution of adverse reactions The prevalence of side effects was calculated by comparing the number of symptoms with the number of patients. The pooled data from the clinical studies and the postmarketing surveillance studies reveal that the most commonly observed side effects were nausea, dizziness, drowsiness, tiredness, sweating, vomiting and dry mouth, with an overall incidence of between 1 and 6%. In the postmarketing surveillance studies on long term and acute administration, the profile of adverse events was qualitatively almost identical to that in the phase II to IV studies. However, there were distinct quantitative differences it favour of the long term studies. In the postmarketing surveillance study on acute parenteral administration, the incidences of nausea and vomiting were only 4.2 and 0.5% respectively, which is significantly lower than the 20.7 and 11.4% in the patient-controlled analgesia studies. Nevertheless, it is important to take into consideration the different conditions in these studies. All the postmarketing surveillance studies were outpatient studies, whereas almost all of the phase II to IV studies were carried out in hospitals. The studies with intravenous and intramuscular administration were mainly postoperative, which explains the relatively high incidence of nausea and vomiting, 17.8 and 7.0%, respectively, with intramuscular administration. The different conditions in the phase II to IV studies and the postmarketing surveillance studies are also reflected in the occurrence of dizziness and postural hypotension: The incidence of dizziness in the postmarketing surveillance studies is slightly higher than that observed in the phase II to IV studies. Particularly in the studies with intravenous and intramuscular administration, the patients were confined to bed and were therefore much less sensitive to dizziness than those in the long term oral and postmarketing surveillance studies, who were all outpatients. On the other hand, postural hypotension played almost no role in the multiple dose studies, in which the oral formulation were used most frequently. It is interesting to note that diarrhoea, pruritus and gastrointestinal disorder (except nausea and vomiting) are mainly reported in the multiple dose studies in the groups receiving oral tramadol, and also in the postmarketing surveillance studies. Once again, the study conditions may well be the explanation. The adverse effects reported in both clinical and postmarketing surveillance studies are similar to those in the spontaneous reports. The most frequently documented adverse effects in clinical and postmarketing surveillance studies, i.e. nausea/vomiting, dizziness, drowsiness, tiredness, sweating and dry mouth, are noted very infrequently in spontaneous reports, since in medical practice these side effects are usually known and are described in the product information. Almost all reports referring to abuse/dependence are connected with pain therapy; they give no reason to suspect any pro
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PMID:[Tolerance and safety of tramadol use. Results of international studies and data from drug surveillance]. 919 Mar 25

In a prospective, double-blind trial we compared the analgesic efficacy of tramadol during the first 24 h after day case laparoscopic sterilisation with two commonly prescribed combination analgesics. Seventy-five women were allocated randomly to receive oral paracetamol 325 mg/dextropropoxyphene hydrochloride 32.5 mg, tramadol 50 mg or paracetamol 500 mg/codeine phosphate 30 mg as required after a standardised anaesthetic technique. There were no significant differences in average or worst pain, sleep disturbance, mobility, number of tablets taken, satisfaction or preference for stronger analgesia (26.2% of all patients). The incidences of nausea and vomiting were comparable between groups. There was a trend towards a lower incidence of central nervous system side-effects (drowsiness, dizziness, headache) in the paracetamol/codeine group. Tramadol may be considered an alternative analgesic for day case surgery although analgesic regimens of greater efficacy are required for many patients. The relative incidence of side-effects for tramadol and other analgesics requires further evaluation.
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PMID:Analgesia after day case laparoscopic sterilisation. A comparison of tramadol with paracetamol/dextropropoxyphene and paracetamol/codeine combinations. 924 23

An 11-year-old boy suffered an inadvertent dural puncture during placement of an epidural catheter for postoperative analgesia. He developed symptoms of mild headache only, but severe and protracted orthostatic nausea and dizziness, which eventually resolved completely following epidural blood patch. His symptoms were atypical and could have been misinterpreted in the context of dural puncture for diagnosis, or for administration of intrathecal chemotherapy. The reported incidence of headache following dural puncture in children is low. It may be that the manifestations are different from those of adults and that the true incidence of symptoms related to leakage of cerebrospinal fluid is higher in children than currently recognised.
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PMID:Postdural puncture symptoms in a child. 924 30

Given the inherent side effects associated with both opioid and nonopioid analgesic drugs, a nonpharmacologic therapy that could decrease the need for analgesic medication would be valuable. We designed a sham-controlled study to assess the effect of the intensity of transcutaneous acupoint electrical stimulation (TAES) on postoperative patient-controlled analgesia (PCA) requirement for hydromorphone (HM), the incidence of opioid-related side effects, and the recovery profile after lower abdominal surgery. One hundred one healthy consenting women undergoing lower abdominal procedures with a standardized general anesthetic technique were randomly assigned to one of four postoperative analgesic treatment regimens: Group I (n = 26) PCA only; Group II (n = 25), PCA + sham-TAES (no electrical stimulation); Group III (n = 25), PCA + low-TAES (4-5 mA of electrical stimulation); Group IV (n = 25), PCA + high-TAES (9-12 mA of electrical stimulation). The PCA device was programmed to deliver HM, 0.2-0.4 mg intravenously boluses "on demand," with a minimum lockout interval of 10 min. The TAES skin electrodes were placed at the Hegu acupoint on the nondominant hand and on both sides of the surgical incision. The TAES frequency was set in the dense-and-disperse mode, alternating at 2 Hz and 100 Hz every 3 s, with stimulation of the hand and incision alternated every 6 s. The patients in Groups II-IV were instructed to use TAES every 2 h for 30 min while awake. After discontinuation of PCA, oral pain medications were administered on demand. The postoperative PCA-HM requirement, pain scores, opioid-related side effects, and requirements for antiemetic and antipruritic medication were recorded. High-TAES decreased the HM requirement by 65% and reduced the duration of PCA therapy, as well as the incidence of nausea, dizziness, and pruritus. Low-TAES produced a 34% decrease in the HM requirement compared with only 23% in the "sham" TAES group. We conclude that high-TAES produced a significant decrease in the PCA opioid requirement and opioid-related side effects after low intraabdominal surgery.
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PMID:Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. 924 22


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