Anesthesia and analgesia
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Anesthesia and analgesia · Sep 2003
Randomized Controlled Trial Multicenter Study Clinical TrialThe antiemetic efficacy of droperidol added to morphine patient-controlled analgesia: a randomized, controlled, multicenter dose-finding study.
The antiemetic dose response of droperidol when it is added to patient-controlled analgesia with morphine is not well known. We randomly allocated adults who received postoperative morphine patient-controlled analgesia (1-mg bolus, 5-min lockout) to one of four regimens: no droperidol (control) or 5, 15, or 50 micro g of droperidol per milligram of morphine. Efficacy and adverse effects were recorded during 24 h and were analyzed with number needed to treat (NNT) and number needed to harm with 95% confidence intervals. ⋯ There was no difference in patient satisfaction. The optimal antiemetic dose of droperidol is 15-50 micro g/mg of morphine. Larger doses may have more antivomiting efficacy but are likely to be unacceptably sedating.
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Multicenter Study Clinical TrialDiaspirin-crosslinked hemoglobin reduces blood transfusion in noncardiac surgery: a multicenter, randomized, controlled, double-blinded trial.
In this randomized, prospective, double-blinded clinical trial, we sought to investigate whether diaspirin-crosslinked hemoglobin (DCLHb) can reduce the perioperative use of allogeneic blood transfusion. One-hundred-eighty-one elective surgical patients were enrolled at 19 clinical sites from 1996 to 1998. Selection criteria included anticipated transfusion of 2-4 blood units, aortic repair, and major joint or abdomino-pelvic surgery. Once a decision to transfuse had been made, patients received initially up to 3 250-mL infusions of 10% DCLHb (n = 92) or 3 U of packed red blood cells (PRBCs) (n = 89). DCLHb was infused during a 36-h perioperative window. On the day of surgery, 58 of 92 (64%; confidence interval [CI], 54%-74%) DCLHb-treated patients received no allogeneic PRBC transfusions. On Day 1, this number was 44 of 92 (48%; CI, 37%-58%) and decreased further until Day 7, when it was 21 of 92 (23%; CI, 15%-33%). During the 7-day period, 2 (1-4) units of PRBC per patient were used in the DCLHb group compared with 3 (2-4) units in the control patients (P = 0.002; medians and 25th and 75th percentiles). Mortality (4% and 3%, respectively) and incidence of suffering at least one serious adverse event (21% and 15%, respectively) were similar in DCLHb and PRBC groups. The incidence of jaundice, urinary side effects, and pancreatitis were more frequent in DCLHb patients. The study was terminated early because of safety concerns. Whereas the side-effect profile of modified hemoglobin solutions needs to be improved, our data show that hemoglobin solutions can be effective at reducing exposure to allogeneic blood for elective surgery. ⋯ In a randomized, double-blinded red blood cell controlled, multicenter trial, diaspirin-crosslinked hemoglobin spared allogeneic transfusion in 23% of patients undergoing elective noncardiac surgery. The observed side-effect profile indicates a need for improvement in hemoglobin development.
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Anesthesia and analgesia · Jan 2003
Randomized Controlled Trial Multicenter Study Clinical TrialInterscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine.
We compared the onset time and quality of interscalene brachial plexus block produced with levobupivacaine and ropivacaine in 50 patients undergoing open shoulder surgery randomly allocated to receive 30 mL of 0.5% levobupivacaine (n = 25) or 0.5% ropivacaine (n = 25) injected through a 20-gauge catheter placed into the interscalene sheath using a 18-gauge insulated and stimulating Tuohy introducer. The block was also prolonged after surgery using a patient-controlled interscalene analgesia with 0.125% levobupivacaine or 0.2% ropivacaine, respectively (basal infusion rate, 6 mL/h; bolus, 2 mL; lockout period, 15 min; maximum boluses per hour, three). Three patients (two with levobupivacaine [8%] and one with ropivacaine [4%]) failed to achieve surgical block within 45 min after the injection and were excluded. The onset time of surgical block was 20 min (10-40 min) with levobupivacaine and 20 min (5-45 min) with ropivacaine (P = 0.53). Rescue intraoperative analgesia (0.1 mg of fentanyl IV) was required in eight patients in each group (34%) (P = 0.99). Forty-two patients completed the 24-h postoperative infusion (22 with levobupivacaine and 20 with ropivacaine). Postoperative analgesia was similarly effective in both groups. Total consumption of local anesthetic infused during the first 24 h was 147 mL (144-196 mL) with levobupivacaine and 162 mL (144-248 mL) with ropivacaine (P = 0.019), with a ratio between boluses received and requested of 0.8 (0.4-1.0) and 0.7 (0.4-1.0), respectively (P = 0.004). The degree of motor block of the operated limb was deeper with levobupivacaine than ropivacaine when starting postoperative analgesia; however, no further differences in degree of motor function were observed between the two groups. We conclude that 30 mL of levobupivacaine 0.5% induces an interscalene brachial plexus anesthesia of similar onset and intensity as the one produced by the same volume and concentration of ropivacaine. Postoperative interscalene analgesia with 0.125% levobupivacaine results in similar pain relief and recovery of motor function with less volume of local anesthetic than with 0.2% ropivacaine. ⋯ This prospective, randomized, double-blinded study demonstrates that 30 mL of 0.5% levobupivacaine produces an interscalene brachial plexus block of similar onset and quality as the one produced by the same volume of 0.5% ropivacaine. When prolonging the block after surgery, 0.125% levobupivacaine provides adequate pain relief and recovery of motor function after open shoulder surgery, with less volume infused during the first 24 h after surgery than 0.2% ropivacaine.
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Anesthesia and analgesia · Aug 2002
Randomized Controlled Trial Multicenter Study Clinical TrialAprotinin versus placebo in major orthopedic surgery: a randomized, double-blinded, dose-ranging study.
We conducted a prospective, multicenter, double-blinded, dose-ranging study to compare the risk/benefit ratio of large- and small-dose aprotinin with placebo after major orthopedic surgery. Fifty-eight patients were randomized into three groups: Large-Dose Aprotinin (4 M kallikrein inactivator unit [KIU] bolus before surgery followed by a continuous infusion of 1 M KIU/h until the end of surgery), Small-Dose Aprotinin (2 M KIU bolus plus 0.5 M KIU/h), and Placebo. Bleeding was measured and calculated. Bilateral ascending venography was systematically performed on the third postoperative day. Measured and calculated blood loss decreased in the Large-Dose Aprotinin group (calculated bleeding, whole blood, hematocrit 30%, median [range], 2,023 mL [633-4,113] as compared with placebo, 3,577 mL [1,670-21,758 mL]). The total number of homologous and autologous units was also significantly decreased in the Large-Dose Aprotinin group (2 U [0-5 U] as compared with placebo, 4 U [0-42 U]). No increase in deep vein thrombosis or pulmonary embolism was observed in the aprotinin groups. Large-dose aprotinin was safe and effective in dramatically reducing the measured and calculated bleeding and the amount of transfused red blood cell units after major orthopedic surgery. ⋯ Large doses of aprotinin decrease blood loss and transfusion amount in major orthopedic surgery.
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Anesthesia and analgesia · Jun 2002
Randomized Controlled Trial Multicenter Study Clinical TrialAn evaluation of the efficacy and tolerability of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children.
In this double-blinded, randomized, multicenter study, we examined analgesic efficacy and tolerability of tramadol in postoperative pediatric patients. Eighty-one postsurgical ASA physical status I and II patients ages 7-16 yr received oral tramadol (approximately 1 or 2 mg/kg) for postoperative analgesia when they were ready to transition from morphine patient-controlled analgesia to oral analgesics. Rescue analgesia consisted of morphine patient-controlled analgesia or an oral equivalent dose of oxycodone. Patients rated their pain just before the administration of tramadol and at regular intervals for 8 h afterwards using the Wong-Baker Faces Pain Rating Scale. The 2-mg/kg group required approximately half as much rescue analgesia as the 1-mg/kg group (P = 0.006). Parents rated the larger dose more favorably. Adverse events were generally mild to moderate in severity (vomiting [10%], nausea [9%], pruritus [7%], rash [4%]) and similar between the two treatment groups. There were no significant changes in hemodynamic variables, respiratory rate, or SpO(2) percentages between the two treatment groups or in all patients compared with pretreatment values. ⋯ Oral tramadol 1-2 mg/kg is well tolerated and effective in postoperative children ready to transition from morphine patient-controlled analgesia. The group receiving 2 mg/kg required less rescue analgesic compared with those receiving 1 mg/kg.