A randomised controlled trial on the efficacy and side‐effect profile (nausea/vomiting/sedation) of morphine‐6‐glucuronide versus morphine for post‐operative pain relief after major abdominal surgery*

Morphine is the first choice of treatment of severe post‐operative pain, despite the occurrence of often discomforting (post‐operative nausea or vomiting (PONV)) and sometimes dangerous (sedation, respiratory depression) side effects. Literature data indicate that morphine's active metabolite, morphine‐6‐glucuronide (M6 g), is a powerful analgesic with a possibly more favourable side‐effect profile. In this multi‐centre randomised controlled clinical trial patients undergoing major abdominal surgery were randomised to M6 g or morphine treatment. Treatment started 30–60 min prior to the end of surgery and was continued postoperatively, after patients were titrated to comfort, via patient‐controlled analgesia (PCA) for 24–48h. Pain intensity, nausea, vomiting and sedation scores were collected at regular intervals. In the study 268 patients were randomised to M6 g and 249 to morphine. Withdrawal due to insufficient pain relief occurred predominantly just after surgery and was higher in the M6 g group (16.8%) than in the morphine group (8.8%), suggesting a slower onset of analgesia for M6 g compared to morphine. Subjects who continued on PCA remained equi‐analgesic throughout the study. During the first 24 h, nausea levels showed a 27% difference in favour of M6 g which narrowly failed to reach statistical significance (P =0.052). Sub‐analysis showed a significant reduction in nausea levels in females on M6 g (30% difference, P =0.034). In all patients, similar reductions of 30–35% were observed in anti‐emetic use, vomiting, PONV (a combined measure of nausea and vomiting) in favour of M6 g, persisting for the first 24 h postoperatively. Reductions in sedation were observed in the first 4 h post‐operative period for M6 g patients.     

伍用不同剂量氟哌啶对曲马多PCEA术后镇痛效应的影响

研究不同剂量量氟哌啶对曲马多病人自控硬膜外镇痛（ＰＣＥＡ）效应及副作用的影响。方法：择期手术３２０例随机分为四组,Ａ组（ｎ＝８０）：１％曲马多＋０．１５％丁哌卡因（对照组）;Ｂ组（ｎ＝８０）：１％曲马多＋０．１５％丁哌卡因＋０．００５％氟哌啶;Ｃ组（ｎ＝８０）：１％曲马多＋０．１５％丁哌卡因＋０．０１％氟哌啶;Ｄ组（ｎ＝８０）：１％曲马多＋０．１５％丁哌卡因＋０．０１５％氟哌啶。上述各组按比例配制     

Comparison of the antiemetic efficacy of tropisetron and droperidol with patient-given tramadol

We compared the antiemetic efficacy of tropisetron versus droperidol in women given tramadol after total hysterectomy. Forty patients were randomly allocated to group 1 (n = 20, tropisetron 0.05 mg/kg intravenously) or group 2 (n = 20, droperidol 15 micrograms/kg intravenously). Tramadol infusion (intravenously), for post-operative analgesia, was started at fascia closure. Incidences of post-operative nausea and vomiting, pain intensity, tramadol use, and the need for a rescue antiemetic (metoclopramide 10 mg) were recorded 0 h, 2 h, 6 h, 12 h, 24 h and 48 h post-operatively. Vomiting and nausea incidences were reported fewer in group 1 than in group 2, but statistical significance was only reached for vomiting incidence 6 h post-operation. Tropisetron seems to have better antiemetic properties than droperidol in patients receiving tramadol because of the length of its duration of action. Further studies, investigating alternative ways of managing post-operative nausea and vomiting, and the use of tramadol for post-operative analgesia, are needed.     

Comparison of dexmedetomidine and midazolam for monitored anesthesia care combined with tramadol via patient-controlled analgesia in endoscopic nasal surgery: A prospective, randomized, double-blind, clinical study

Abstract

Background

Monitored anesthesia care (MAC) may be applied for septoplasty or endoscopic sinus surgery in which an adequate sedation and analgesia without respiratory depression are desired for comfort of both the patient and the surgeon. Several combinations with different agents have been used for this purpose in these patients. However, analgesic properties for these agents have not been reported.

Objective

The aim of this study was to investigate the analgesic and sedative effects of dexmedetomidine or midazolam infusion combined with tramadol that was used via patient-controlled analgesia (PCA), and to document the effects of these drugs on early cognitive functions.

Methods

This prospective, randomized, double-blind, clinical study enrolled patients undergoing septoplasty or endoscopic sinus surgery at the Abant Izzet Baysal University Hospital, Bolu, Turkey, between February and September 2006. Patients were randomly allocated in a 1:1 ratio into 1 of 2 groups: the dexmedetomidine group (group D) patients received IV dexmedetomidine 1 μg/kg for 10 minutes followed by continuous infusion of 0.5 μg/kg · h⁻¹; and the midazolam group (group M) patients were administered a loading dose of IV midazolam 40 μg/kg for 10 minutes followed by infusion at the rate of 50 μg/kg · h⁻¹. A 1-minute bolus dose of IV tramadol (1.5 mg/kg) was administered in both groups 10 minutes after the administration of the primary drug, and continued via infusion using a PCA device. After baseline measurements, systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation, and rate of respiration were recorded after the loading dose of study drug, after the bolus tramadol dose, at 10-minute intervals during the operation, and twice in the recovery rooms; 5 minutes after arrival and 5 minutes before discharge. Verbal rating score (VRS) and Ramsay sedation score were determined at baseline (after surgery was started), every 10 minutes thereafter until the end of the operation, and 2 times during recovery. All patients were assessed with the Wechsler Memory Scale-Revised at baseline (preoperatively) and 4 hours after the operation.

Results

Seventy patients were enrolled in the study and randomly assigned to 1 of 2 groups: group D (sex, male/female, 23/12; mean [SEM] age, 32.53 [2.07] years; mean [SEM] weight, 73.03 [2.41] kg) or group M (sex, male/female, 21/14; mean [SEM] age, 34.43 [1.83] years; mean [SEM] weight, 67.90 [2.32] kg). All hemodynamic parameters (SAP, DAP, MAP, HR) were significantly higher in group M compared with group D from the onset of the surgery to discharge time (P < 0.05). Pain and sedation scores were similar in both groups, but the amount of PCA-administered rescue tramadol was significantly higher in group M (P = 0.001). A higher, though not statistically significant, prevalence of adverse events (ie, hypotension, bradycardia, and perioperative nausea and vomiting) were observed in group D. Postoperative logical verbal memory and digit span values were significantly higher in group D when compared with group M (P < 0.05). Postoperative digit span and visual reproduction scores were significantly higher than preoperative values in group D (P < 0.05). Postoperative personality functioning scores were significantly higher than preoperative values in group M (P < 0.05).

Conclusions

Based on VRS, Ramsay sedation scores, and surgeon and anesthesiologist satisfaction scores, dexmedetomidine or midazolam combined with tramadol PCA provided adequate analgesia and sedation in these adult patients undergoing septoplasty or endoscopic sinus surgery with MAC. A significantly larger amount of rescue tramadol was used by group M, suggesting that a better analgesic effect was achieved with dexmedetomidine.Key Words: dexmedetomidine, midazolam, sedoanalgesia, cognitive function     

老年病人腹部手术后镇痛剂量的探讨

目的：探讨静脉和硬膜外镇痛用于老年病人腹部手术后镇痛的剂量。方法：全麻腹部手术病人120例，年龄65-99岁，随机分六组；V1～V3组术毕经静脉自控镇痛，药液配方为每100ml生理盐水内含曲马多501）mg、芬太尼0．5mg、氟哌利多2．5mg；负荷量和背景量分别为V．组2ml、1．0ml／h，Ⅵ组3ml、1．5ml／h，U组4ml、1．5ml／h。E1～E3组硬膜外自控镇痛，药液为每100ml内含吗啡5mg、布比卡因100mg、氟哌利多2．5mg；负荷量和背景量分别为E1组2ml、1．0ml／h，E2组3ml、1．5ml／h，E3组4ml、1．5ml／h。PCA单次量2ml、锁定时间10min。记录2h、6h、12h、24h、48h疼痛、镇静和总舒适评分、镇痛用药量、PCA按压次数、有效按压率（D／D）及不良反应发生率。结果：镇痛用药量：V1组〉V2组，U组〉V1组，E3组〉B组，E3组〉E1组（均P〈0．05）。按压次数：E1组〉E3组，E1组〉B组（P％0．05），其余各组间无显著性差异。有效按压率（D／D）：静脉组中无显著差异，E1组〉E3组，E1组〉B组（均P％0．05）。疼痛评分：静脉组中无显著差异，E1组〉E3组，E1组〉R组（均P％0．05）。镇静评分：V1组〉V1组、V2组〉V1组（P〈0．05），硬膜外组中无显著差异。总舒适评分：E2组〉V1组（P〈0．05）。不良反应：恶心、呕吐V3组3次、B组4次，明显多于其他组；眩晕V3组4次；V1和V2组分别有4例和3例病人排气时问明显延长。结论：老年病人腹部手术后镇痛静脉组中，负荷量2ml、背景输注量1．0ml／h效果较佳。最适宜方式是吗啡硬膜外镇痛，剂量为：负荷量2～4ml、背景输注量1．2ml／h。     

Efficacy and safety of low-dose transdermal buprenorphine patches (5, 10, and 20 μg/h) versus prolonged-release tramadol tablets (75, 100, 150, and 200 mg) in patients with chronic osteoarthritis pain: A 12-week,randomized, open-label,controlled, parallel-group noninferiority study

Objective: This study compared the efficacy and safety of low-dose 7-day buprenorphine patches and prolonged-release tramadol tablets in patients with chronic, moderate to severe osteoarthritis (OA) pain of the hip and/or knee.Methods: Eligible patients were adults with a clinical and radiologic diagnosis of OA of the hip and/or knee and moderate to severe pain, as confirmed by a mean Box Scale 11 (BS-11) score ≥4 while using paracetamol 4000 mg/d for pain during the screening week. Patients were randomized in a 1:1 ratio to receive either low-dose 7-day buprenorphine patches (patch strengths of 5, 10, and 20 μg/h, with a maximum dosage of 20 μg/h) or twice-daily prolonged-release tramadol tablets (tablet strengths of 75, 100, 150, and 200 mg, with a maximum dosage of 400 mg/d) over a 12-week open-label treatment period. Supplementary paracetamol was available as rescue medication throughout the study. The primary end point was the difference in BS-11 scores from baseline to the completion of treatment. Noninferiority was assumed if the treatment difference on the BS-11 scale was ?1.5 boxes, indicating a clinically meaningful result. Secondary efficacy variables were rescue medication use, sleep disturbance and quality of sleep, and patients' and investigators' global assessments of pain relief. In addition, patient preference was assessed at the completion visit by asking patients whether, given equal pain relief, they would prefer basic treatment for OA pain with a patch applied once weekly or a tablet taken twice daily. Exploratory variables included investigators' assessments of patients' pain, stiffness, and ability to perform daily activities (Western Ontario and McMaster Universities Osteoarthritis Index); patients' quality of life (EuroQol EQ-5D health states index and EuroQol visual analog scale); and abuse and diversion of study drug.Results: One hundred thirty-four patients (69 receiving 7-day buprenorphine patches and 65 receiving tramadol tablets) were randomized and received ≥1 dose of study medication. A respective 98.6% and 100% of the 2 treatment groups were white, with mean (SD) ages of 64.4 (11.1) and 64.2 (9.3) years. Both treatments were associated with a clinically meaningful reduction in pain from baseline to study completion. The least squares mean change from baseline in BS-11 scores in the 7-day buprenorphine patch and tramadol tablet groups was ?2.26 (95% CI, ?2.76 to ?1.76) and ?2.09 (95% CI, ?2.61 to ?1.58). The efficacy of 7-day buprenorphine patches was noninferior to that of prolonged-release tramadol tablets. The incidence of adverse events (AEs) was comparable in the 2 treatment groups: 226 AEs were reported in 61 patients (88.4%) in the 7-day buprenorphine patch group, and 152 AEs were reported in 51 patients (78.5%) in the tramadol group. Ten patients (14.5%) in the 7-day buprenorphine patch group and 19 (29.2%) in the tramadol tablet group withdrew from the study due to AEs. The most common AEs in the 7-day buprenorphine patch group were nausea (30.4%), constipation (18.8%), and dizziness (15.9%); the most common AEs in the tramadol tablet group were nausea (24.6%), fatigue (18.5%), and pain (12.3%). Most patients (47/67 [70.1%] in the 7-day buprenorphine patch group and 43/61 [70.5%] in the tramadol tablet group) reported that they would prefer a 7-day patch to a twice-daily tablet for future pain treatment.Conclusions: In these patients with chronic, moderate to severe OA pain of the hip and/or knee, 7-day low-dose buprenorphine patches were an effective and well-tolerated analgesic. The buprenorphine patches were noninferior to prolonged-release tramadol tablets. European Union Drug Regulating Authorities Clinical Trials number: 2006-003233-32.     

曲马多自控镇痛在前列腺切除术后的应用

目的观察前列腺术后静脉和硬膜外曲马多患者自控镇痛(PCA)效果.方法90例前列腺切除患者随机分为静脉注射曲马多患者自控镇痛(PCIA)组、经硬膜外曲马多患者自控镇痛(PCEA)组和未使用术后镇痛(对照)组,每组30例.曲马多负荷量为1 mg/kg.术后定时进行镇静、镇痛评分、24 h曲马多用量、患者满意度、膀胱痉挛次数、膀胱痉挛时间、膀胱冲洗液转清时间及不良反应观察.结果PCIA和PCEA组患者术后视觉模拟评分低于对照组(P＜0.05),镇痛满意度好于对照组(P＜0.05);PCIA组24 h用药量、按键次数及VAS评分均明显低于PCEA组(P＜0.05),镇静评分、不良反应发生率与PCEA组无显著性差异.结论曲马多用于前列腺切除术后镇痛安全有效,且静脉注射镇痛效果优于硬膜外给药.     

Effect of Rectal Diclofenac in Reducing Postoperative Pain and Rescue Analgesia Requirement after Cardiac Surgery

Background:   Adequate analgesic medication is mandatory after coronary artery bypass grafting (CABG) surgery. The aim of this study was to assess the analgesic efficacy, side effects, and need for rescue analgesia after CABG surgery comparing diclofenac and placebo rectal suppository.
Methods:   Thirty-seven consenting adults undergoing elective CABG surgery were randomly assigned in a double-blind fashion to receive either rectal diclofenac 100 mg (Group 1, n  = 19) or placebo suppository (Group 2, n  = 18) postoperatively, just after extubation. Both groups were given intravenous tramadol as a rescue analgesic. Pain scores in the two groups were assessed on a 10-cm visual analog scale at 0, 0.5, 1, 1.5, 2, 6, 12, 18, and 24 hours after suppository administration. Rescue analgesic consumption, sedation, nausea, and vomiting in both the groups were also recorded.
Results:   Twenty-four-hour tramadol consumption in Group 1 was 92.5 ± 33.5 mg compared to 157.5 ± 63.4 mg in Group 2 ( P  = 0.002). Patients in the placebo group had significantly greater pain scores 1.5 to 12 hours after extubation. Group 1 patients were significantly more awake compared to Group 2 ( P  < 0.05). The incidence of postoperative nausea was less in Group 1 than in Group 2 ( P  = 0.001). Though not statistically significant, three patients in Group 2 each had a single episode of vomiting, whereas no patient had vomiting in Group 1.
Conclusion:   Rectal diclofenac suppository with tramadol provides adequate pain relief after cardiac surgery, and also reduces tramadol consumption and side effects commonly associated with tramadol.     

Randomised controlled trial of patient controlled analgesia compared with nurse delivered analgesia in an emergency department

Objective: To compare effectiveness, safety, and patient satisfaction of patient controlled analgesia (PCA) with titrated, intravenous opioid injections for the management of acute traumatic pain in the emergency department (ED).

Methods: The study took place in the ED of a teaching hospital. Patients suffering traumatic injury requiring opioid analgesia, and meeting other inclusion criteria, were consented and randomised to either the study group or control group. The study group were given morphine through the PCA system, whereas the control group were given morphine via the conventional route of nurse titration. Pain levels were measured using a visual analogue scale. Both groups had their vital signs (blood pressure, pulse, oxygen saturations, Glasgow coma score, respiratory rate) and pain scores monitored at 0, 15, 30, 45, 60, 90, and 120 minutes, and any adverse events were noted. Patients were followed up with a questionnaire asking about their experience of pain relief in the department.

Results: 86 patients were recruited to the study, 43 in each group. There was no significant difference between the groups in terms of pain relief (p = 0.578) and patient satisfaction (p = 0.263). No severe adverse events were observed, although 20.7% (n = 9) of the PCA group experienced mild sedation compared with 7% (n = 3) of the control group.

Conclusions: PCA is at least as effective as titrated intravenous injections for relief of traumatic pain. It has considerable potential for use in the ED.

     

Superior postoperative analgesic efficacy of a continuous infusion of tramadol and dipyrone (metamizol) versus tramadol alone

In this prospective, randomised and double-blind clinical study the analgesic efficacy of a continuous infusion of tramadol combined with the non-opioid dipyrone (metamizol) was compared with tramadol alone or with placebo during first 24 h postoperatively. Ninety patients were allocated to the three study groups. In group 1, patients received 600 mg tramadol with 2.5 mg droperidol (DHB); in group 2, 600 mg tramadol together with 4.0 g dipyrone and 2.5 mg DHB; and in group 3, only 2.5 mg DHB. Additionally, a patient-controlled analgesia (PCA) device with morphine was provided to each patient as a rescue in the case of insufficient pain relief. Pain at rest and during movement was measured with a visual analogue scale (VAS, 0–10) during the study time. Side effects and vital parameters were also recorded. After the 24 h study period, a significant pain relief was observed in all three groups. The consumption of morphine via PCA, however, was significantly lower in group 2 (tramadol/dipyrone) than in the tramadol or the placebo group, and also the patients in group 1 (tramadol) had received significantly less morphine than those in the placebo group. Our data suggest a significantly superior analgesic efficacy of a continuous infusion of tramadol combined with dipyrone compared to an infusion of tramadol alone or placebo.     

Efficacy of Preventive Analgesia with Tramadol or Lornoxicam for Percutaneous Nephrolithotomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Background: Prevention of postoperative pain provides better and more rapid convalescence for patients.Objective: The aim of this study was to compare the preventive analgesic effect of tramadol and lornoxicam in the early postoperative period in patients undergoing percutaneous nephrolithotomy (PCNL).Methods: Patients who were scheduled for elective PCNL at the Cumhuriyet University Hospital, Sivas, Turkey, were enrolled in this prospective, double-blind, placebo-controlled study. The patients were randomly assigned to 1 of 3 groups: tramadol, lornoxicam, and normal saline (NS). Ten minutes before induction of anesthesia, the tramadol group received tramadol 100 mg IV, the lornoxicam group received lornoxicam 8 mg IV, and the NS group received NS 2 mL IV. Anesthesia was induced using fentanyl 1 μg/kg and thiopental sodium 4 to 7 mg/kg. Vecuronium 0.1 mg/kg was used for muscle relaxation. Desflurane 4% to 6% and 50%:50% oxygen/nitrous oxide were used for maintenance. Oxygen saturation, heart rate, and mean blood pressure were recorded before induction and during the postoperative period. During the postoperative period, visual analogue scale O/AS) scores, time to first analgesic (TFA), total analgesic consumption (TAC), and patient satisfaction scores were determined. Data about postoperative nausea and vomiting and other adverse events and complications were also collected.Results: Seventy-three patients were assessed for enrollment and 60 (33 women, 27 men; mean [SD] age, 44.69 [11.27] years; age range, 20-62 years) were included in the study. The baseline demographic characteristics and duration of surgery were similar in all 3 groups. The mean (SD) VAS scores in the tramadol group were significantly lower than in the NS group at 15 and 30 minutes and 1, 2, 4, and 12 hours after surgery (all, P < 0.05). The VAS scores in the lornoxicam group were significantly lower than in the NS group at 15 and 30 minutes and 1 hour (all, P < 0.05). The VAS score at 1 hour after surgery was significantly lower in the tramadol group than in the lornoxicam group (18 [8] vs 32 [16]; P < 0.05); however, there were no other significant differences in VAS scores between the active groups. A significantly shorter TFA was associated with the NS group when compared with the tramadol and lornoxicam groups (46 [27] vs 354 [187] and 180 [118], respectively; both, P < 0.05). TFA was significantly shorter in the lornoxicam group when compared with the tramadol roup (180 [118] vs 354 [187]; P < 0.05). TAC was significantly higher in the NS group than in the tramadol and lornoxicam groups (270 [47] vs 115 [74] and 145 [72], respectively; both, P < 0.05). Patient satisfaction score (range) was significantly lower in the NS group when compared with the tramadol and lornoxicam groups (0 [0-1] vs 3 [0-3] and 2 [0-3], respectively; both, P < 0.05). There were no other significant between-group differences observed.Conclusions: Tramadol and lornoxicam were more effective than NS in preventing early postoperative pain. The preventive analgesic effect of tramadol was comparable with that of lornoxicam, except at 1 hour when tramadol was more effective among these patients undergoing PCNL. Both drugs were well tolerated.     

皮下PCA与静脉PCA用于心脏外科术后镇痛疗效的比较

目的 :评价经静脉和皮下吗啡PCA的疗效、安全性及实用性。方法 :将 6 3例ASAI～III级心外科术后病人随机分为吗啡病人自控皮下镇痛 (scPCA)与病人自控静脉镇痛 (ivPCA )组 ,其中scPCA组 31例 ,ivPCA组 32例。药物为吗啡 1mg/ml 利多卡因 10mg/ml的混合液。PCA设置 :负荷量 2ml;单次剂量 1ml;小时限量 10ml/h ;锁定时间 3分钟。于负荷量注射完毕后记录镇痛起效时间 ,并于放置PCA泵后 2 4、4 8、72小时记录疼痛VAS评分、镇静程度、MAP、HR、RR、SPO2 、PCA需求按压和有效按压次数及副作用。结果 :ivPCA组镇痛起效时间显著短于scPCA组 (P <0 .0 5 ) ;两组疼痛评分及副作用发生率无显著性差异。scPCA组PCA泵报警次数显著低于ivPCA组 (P <0 .0 5 )。结论 :吗啡scPCA与ivPCA的疗效和副作用无显著性差异 ,但吗啡scPCA操作简单、系统故障发生率低 ,适于较长时间留置。     

氯诺昔康及曲马多行术后自控镇痛的临床应用

目的评价氯诺昔康及曲马多用于患者术后自控镇痛(PCA)的安全性及有效性,寻找较好的术后自控镇痛方法从而减轻术后护理的工作量和提高患者术后护理质量。方法50例在全麻下行胆囊切除术和单侧乳癌根治术的患者,随机分为氯诺昔康组(L组)和曲马多组(T组),每组各25例。将所配制药液注入PCA泵,PCA泵给药速率为2ml/h,术毕时启动PCA泵进行镇痛,术毕前予首量。镇痛结束时,由患者完成疼痛的评分,记录PCA期间出现的副作用。结果L组患者的镇痛效果优于T组,差异有统计学意义。T组恶心与呕吐的发生率为36.0%,L组为8.0%,T组明显高于L组(P<0.05)。结论氯诺昔康术后自控镇痛的效果优于曲马多,恶心、呕吐少,能减少术后护理工作量,更适用于治疗术后急性疼痛。     

Pediatric patient-controlled analgesia with morphine versus meperidine.

To assess prospectively any difference in either analgesia or side effect frequency with morphine versus meperidine, 50 patients, ages 8-16 years, were randomly assigned to receive postoperative patient-controlled analgesia (PCA) with either morphine or meperidine. A numerical rating scale pain score was obtained from each patient twice a day, and any nausea, vomiting, pruritis, or urinary retention requiring catheterization was noted. No significant difference in the incidence of side effects was noted between the morphine and meperidine groups; however, pain scores during morphine PCA were significantly less than those during meperidine PCA (P less than 0.001). These results suggest that morphine is the better opioid for pediatric PCA.     

Management of Acute Undifferentiated Agitation in the Emergency Department: A Randomized Double-Blind Trial of Droperidol, Ziprasidone, and Midazolam

Objectives: To compare the efficacy of sedation, need for rescue sedation, rates of respiratory depression, and complications of droperidol, ziprasidone, and midazolam when used for the treatment of emergency department (ED) patients requiring sedation for acute undifferentiated agitation. Methods: A prospective, randomized, double-blind trial of agitated ED patients requiring emergent sedation was performed. Patients were randomized to receive droperidol 5 mg, ziprasidone 20 mg, or midazolam 5 mg intramuscularly. Interval measurements were made at 0, 15, 30, 45, 60, and 120 minutes and included Altered Mental Status Scale (AMS) scores, oxygen saturations, and end-tidal carbon dioxide levels. Results: A total of 144 patients were enrolled; 50 patients received droperidol, 46 received ziprasidone, and 48 received midazolam. Adequate sedation (mean AMS score <0) was achieved at 15 minutes in patients receiving midazolam (mean AMS score, −0.81) and 30 minutes for patients receiving droperidol (mean AMS score, −1.3) and ziprasidone (mean AMS score, −0.74). Rescue medication for sedation was necessary in 38 of 144 patients (droperidol, 5 of 50; ziprasidone, 9 of 46; midazolam, 24 of 48; p < 0.05). No cardiac dysrhythmias were identified in any treatment group. Respiratory depression that clinically required treatment with supplemental oxygen occurred in 21 of 144 patients (droperidol, 4 of 50; ziprasidone, 7 of 46; midazolam, 10 of 48; p = 0.20). No patients required endotracheal intubation. Conclusions: Acutely agitated ED patients sedated with droperidol or ziprasidone required rescue medications to achieve adequate sedation less frequently than those sedated with midazolam. The onset of adequate sedation is delayed with ziprasidone, relative to the other agents.     

Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter,randomized, double-blind,placebo-controlled outpatient study

BACKGROUND: Tramadol and acetaminophen (APAP) have both shown efficacy in the treatment of lower back pain. The combination of these 2 agents has demonstrated synergistic analgesic action in animal models at specific ratios. OBJECTIVE: This study assessed the long-term (3-month) efficacy and safety of tramadol 37.5 mg/APAP 325 mg combination tablets in the treatment of chronic lower back pain. METHODS: Patients with at least moderate lower back pain (pain visual analog [PVA] score >/=40 mm on a 100-mm scale) were randomized to receive up to 8 tablets of tramadol/APAP per day or placebo for 91 days. Medication was titrated from 1 to 4 tablets/d by day 10. The primary efficacy measure was PVA score at the final visit. Secondary measures included scores on the Pain Relief Rating Scale (PRRS), Short-Form McGill Pain Questionnaire (SF-MPQ), Roland Disability Questionnaire (RDQ), and 36-Item Short-Form Health Survey (SF-36); the incidence of discontinuation due to insufficient pain relief (Kaplan-Meier analysis); and overall assessments of medication by the patients and investigators. RESULTS: Three hundred eighteen patients (161 tramadol/APAP, 157 placebo) were included in the intent-to-treat population, defined as all patients who took >/=1 dose of study medication and had >/=1 postrandomization efficacy measurement. The mean age of the study population was 53.9 years, 63.2% were female, 90.3% were white, and the mean baseline PVA score was 70.0 mm. There were no significant differences between groups at baseline. Tramadol/APAP significantly improved final PVA scores (P = 0.015) and final PRRS scores (P < 0.001) compared with placebo. Tramadol/APAP also significantly improved RDQ scores (P 相似文献   

Does co-treatment with ultra-low-dose naloxone and morphine provide better analgesia in renal colic patients?

ObjectiveThis study attempted to evaluate the efficacy of ultra-low-dose intravenous (IV) naloxone combined with IV morphine, as compared to IV morphine alone, in terms of reducing pain and morphine-induced side effects in patients with renal colic.MethodsIn this double-blind clinical trial, 150 patients aged 34 to 60 years old who presented to the emergency department (ED) with renal colic were randomly allocated to either an intervention group that received ultra-low-dose IV naloxone combined with IV morphine or to a control group that received morphine plus a placebo. The severity of pain, sedation, and nausea were assessed and recorded for all patients at entrance to the ED (T1), then at 20 (T2), 40 (T3), 60 (T4), 120 (T5), and 180 (T6) minutes after starting treatment. The Numeric Rating Scale (NRS) was used for the assessment of pain and nausea intensities, and the Ramsay Sedation Scale (RSS) was used to assess sedation.ResultsA GEE model revealed that patients in the naloxone group had non-significantly reduced pain scores compared to those in the morphine group (coefficient = ?0.68; 95% CI: ?1.24 to ?0.11, Wald X2 (1) = 5.41, p = 0.02). The sedation outcome demonstrated no statistically significant differences at T1 to T4 among patients with renal colic compared to the ones who only received morphine. At T5 and T6, 1.5% vs. 20% and 1.5% vs. 16.9% of subjects from the naloxone group versus the morphine group obtained RSS scores equal to 3, respectively (p = 0.001 and p = 0.004, respectively).ConclusionsCompared to patients who only received IV morphine, co-treatment of ultra-low-dose naloxone with morphine could not provide better analgesia and sedation/agitation states in renal colic patients.     

氯诺昔康用于学龄儿童术后自控镇痛的临床研究

目的评价氯诺昔康用于小儿术后自控镇痛的安全性及有效性。方法60例拟行臀筋膜松解术的患儿,随机均分为L组(氯诺昔康组)和T组(曲马多组)。均采用硬膜外加氯胺酮分离麻醉。术毕,L组静注氯诺昔康0.15mg/kg为负荷量,继用0.3mg/kg氯诺昔康加生理盐水稀释至100ml后置于PCA泵药池内。T组静注曲马多1mg/kg为负荷量,继用10mg/kg曲马多加生理盐水稀释至100ml后置于PCA泵药池内。PCA泵背景剂量为5ml/h,PCA量为2ml/次,锁定时间为15分钟。记录使用PCA后1h,4h,8h,12h,20h患儿的疼痛评分、对疼痛治疗总体印象评分及所出现的副作用。结果两组患儿镇痛治疗评分及对镇痛治疗总体印象评分,组间对比均无显著性差异(P>0.05);曲马多组出现恶心,呕吐的病例数目明显高于氯诺昔康组(P<0.01);两组患者PCA治疗前后肝肾功能及出凝血时间比较无统计学意义(P>0.05)。结论氯诺昔康用于小儿术后镇痛是安全有效的,可作为小儿术后镇痛治疗的一种选择药物。     

Adolescents use patient-controlled analgesia effectively for relief from prolonged oropharyngeal mucositis pain.

We compared patient-controlled analgesia (PCA) and continuous infusion (CI) morphine delivery in a randomized controlled trial in adolescents during oropharyngeal mucositis pain after bone marrow transplantation. Results from 20 patients who completed 7 or more days on study (10 PCA, 10 CI) were evaluated. The group means for age, weight and height were comparable. Daily measures were morphine intake, self-report of pain intensity and side effect scores. Over 10 study days, the mean cumulative morphine dose to subjects in each group was 4.94 mg/kg (PCA) vs. 12.17 mg/kg (CI); the difference is significant (P less than 0.01). No significant differences were found between the groups for patient ratings of pain intensity or side effect scores despite the large difference in mean morphine intake, but the PCA group tended to report less intense sedation and less difficulty concentrating. Adolescents can use PCA effectively and safely for 1-3 weeks. Morphine intake of adolescent patients using PCA morphine intake is significantly lower than that of similar patients receiving staff-controlled CI.     

Patient-controlled extradural analgesia after caesarean section: a comparison between tramadol,sufentanil and a mixture of both

In a double-blind randomised study into post-operative pain relief by extradural PCA, 66 Caesarean section patients were divided in to three groups to receive either sufentanil (2 μ/ml), tramadol (10 mg/ml) or a mixture of both. After a loading dose of 10 ml, patients were allowed to ask for additional boluses of 2.5 ml, respecting a lock-out time of 10 min and a 1-h limit of 10 ml. Every 6 h, VAS pain scores, consumption of drugs, number of demands and side-effects were registered. At 6 h, pain was significantly less in the combination group compared to patients receiving tramadol alone. The 24-h dose requirements for sufentanil and tramadol when used alone were 123.5±10.3 μg and 652±42 mg, respectively. Combining both drugs decreased the consumption and number of demands for tramadol only (22%, p<0.05 vs 18% for sufentanil, NS). In the tramadol groups, more failures and significantly more side-effects, mainly nausea and vomiting, were noticed. It may be concluded that the extradural use of tramadol is less beneficial than previously reported. Due to disturbing side-effects, relatively high dose requirements (even after the addition of a lipophilic opioid) and somewhat inferior analgesic quality, its extradural administration for postoperative pain relief cannot be recommended.