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1.
In a randomized, single-dose, double-blind, parallel comparative trial of analgesic efficacy, 96 adult patients received either 10 mg ketorolac tromethamine or 400 mg glafenine orally the morning after surgery if they requested pain relief medication. Each patient provided a baseline pain assessment and then received the assigned medication. Patients assessed pain intensity and pain relief and reported any adverse events in interviews held 30 minutes after drug administration and then hourly for 6 hours. The demographic characteristics, baseline pain intensity, and surgical categories of the 47 patients who received ketorolac tromethamine and the 49 who received glafenine were similar. Both drugs provided prompt, sustained pain relief throughout the 6-hour observation period, and there were no statistically significant differences between the two groups in any of the efficacy measures analyzed. The global assessment recorded by patients suggested a slight clinical advantage for ketorolac tromethamine (32.6% of 'excellent' responses) as compared to glafenine (12.5% 'excellent'). The differences in overall response were statistically significant (p = 0.017). Fourteen (30%) patients who received ketorolac tromethamine and 17 (35%) who received glafenine reported adverse experiences that began or seemed to worsen after administration of the study drugs. The most prominent were drowsiness and sleeping, both of which are common in post-surgical patients.  相似文献   

2.
A single-dose, randomized, double-blind study of parallel design was conducted to determine the analgesic efficacy and safety of ketorolac tromethamine in patients who experience moderate or severe pain after the surgical removal of three or more third molars, one of which was a bony-impacted mandibular molar. Meperidine hydrochloride was used as the control analgesic. In this 8-hour study, assessments were made of pain intensity, pain relief, and overall rating of the medication in 145 patients, each of whom had received an intramuscular injection of 10 mg, 30 mg, or 90 mg of ketorolac, or 50 mg or 100 mg of meperidine. The summed pain intensity and total pain relief scores showed that, at 3 and 8 hours, the effectiveness of 30 mg of ketorolac was similar to that of 90 mg ketorolac and that both of these doses were significantly more efficacious than 10-mg ketorolac, 50-mg meperidine, or 100-mg meperidine. Patients who received 30 mg or 90 mg of ketorolac gave the study medication significantly higher ratings overall than did patients who received 50 mg or 100 mg of meperidine. Significantly fewer patients treated with ketorolac reported adverse events in comparison with those treated with meperidine (17% and 59%, respectively), which suggests that it possesses a better therapeutic index than meperidine. Thus, ketorolac appears to represent an important advance in analgesic therapy.  相似文献   

3.
The analgesic efficacy of ketorolac tromethamine was compared to placebo in 126 patients suffering moderate or severe chronic pain due to cancer in a double-blind parallel randomized study. Ketorolac was administered intramuscularly in doses of 10, 30 or 90 mg. Pain intensity and pain relief were assessed for 6 hours by scoring standard verbal scales and an overall assessment of the medication was given by the patients and the observer on completion of the study. Each dose of ketorolac was statistically superior to placebo for the sum of pain intensity difference (SPID) but no difference was seen between the three ketorolac regimens. When the ketorolac groups are combined, there was a significantly better pain relief as compared to placebo. The global evaluation scores were also statistically superior in the ketorolac groups combined than in the placebo group. A total of 15 patients reported minor adverse events, 10 being after ketorolac doses. This study shows that single intramuscular doses of ketorolac of 10 mg and above are effective in the relief of cancer pain, and are associated with a low incidence of side-effects.  相似文献   

4.
林丰  李思齐  袁勇  张力  陈嘉勇 《中国药房》2012,(12):1103-1105
目的:观察酮咯酸氨丁三醇联合盐酸哌替啶治疗肾绞痛的临床疗效。方法:将我院2008年5月-2010年5月收治的中、重度疼痛的肾绞痛患者120例随机均分为3组,均采取肌肉注射药物进行镇痛治疗。其中,Ⅰ组应用酮咯酸氨丁三醇60mg;Ⅱ组应用盐酸哌替啶100mg;Ⅲ组应用酮咯酸氨丁三醇30mg+盐酸哌替啶50mg。记录用药前以及用药后3h内(0、0.5、1、1.5、2、2.5、3h)的疼痛强度、疼痛强度差、疼痛缓解度以判断镇痛效果,并观察各组治疗中的不良反应情况。结果:用药后,3组均在0.5h起效,在中度疼痛的镇痛方面,Ⅲ组在用药3h内的所有观察点均优于Ⅰ、Ⅱ组(P<0.05),在2h时差异最为显著(P<0.01);在重度疼痛的镇痛方面,Ⅲ组在用药1.5、2、2.5、3h时效果优于Ⅰ、Ⅱ组(P<0.05);Ⅲ组的中度以上疼痛缓解程度除0.5h外,其余各点与Ⅰ、Ⅱ组比较,差异均有统计学意义(P<0.05)。Ⅲ组不良反应的发生率小于其他2组(P<0.05)。结论:酮咯酸氨丁三醇联合盐酸哌替啶治疗肾绞痛效果显著,同时可减少盐酸哌替啶的使用量,并可延长镇痛时间,且安全性较好。  相似文献   

5.
Study Objective . To compare ketorolac tromethamine with morphine for pain management after major abdominal surgery. Design . Double-blind, randomized study Setting . Hospital recovery room and postoperative surgical unit. Patients . One hundred ninety-one patients with at least moderate pain after major abdominal surgery. Interventions . Patients received ketorolac by patient-controlled analgesia (PCA) bolus alone (Ket B), ketorolac by bolus plus infusion (Ket I), or morphine by PCA bolus (morphine), with injectable morphine available for supplementation. Measurements and Main Results . Levels of sedation, pain intensity, pain relief, and adverse events were recorded at baseline, at 2, 4, and 6 hours, and at termination. Supplemental morphine was required by 71% of Ket B patients, 67% of Ket I patients, and 38% of morphine patients (p<0.001 for Ket B vs morphine). Although patients receiving ketorolac required more supplemental morphine than the morphine group (6.0 mg Ket I, 6.2 mg Ket B, 4.0 mg morphine), there was a large morphine-sparing effect in both ketorolac groups (total morphine 6.0 mg Ket I, 6.2 mg Ket B, 33.3 mg morphine). Overall pain relief scores were similar for morphine and Ket I groups, and were lower for Ket B than for morphine (p=0.002). There were no differences among groups in numbers of patients with adverse events. Conclusion . Ketorolac may be effective when administered by PCA device, and has a clear morphine-sparing effect. (Pharmacotherapy 1997;17(5):891–899)  相似文献   

6.
Ketorolac, an injectable nonnarcotic analgesic   总被引:4,自引:0,他引:4  
Clinical studies of the injectable nonsteroidal anti-inflammatory agent (NSAIA) ketorolac tromethamine are reviewed, and the chemistry, pharmacology, pharmacokinetics, drug interactions, and adverse effects of ketorolac are described. Ketorolac exhibits anti-inflammatory, analgesic, and antipyretic activity. Although the exact mechanisms of action have not been determined, its effects appear to be associated principally with the inhibition of prostaglandin synthesis. After oral, i.m., or i.v. administration, ketorolac and its metabolites are excreted mainly in urine. Ketorolac tromethamine has been used for the symptomatic relief of moderate to severe postoperative pain, including that associated with abdominal, gynecologic, oral, orthopedic, or urologic surgery. Ketorolac has also been used for the relief of acute renal colic, pain associated with trauma, and visceral pain associated with cancer. When administered i.m., ketorolac produced analgesia comparable to that of i.m. doses of meperidine, pentazocine, or morphine. The most common adverse effects associated with short-term administration are nervous system and gastrointestinal effects; these are usually mild and occur in about 39% of patients. Unlike opiate analgesics, ketorolac does not appear to cause tolerance or physical dependence in patients receiving long-term therapy. Ketorolac tromethamine has been administered concomitantly with morphine or meperidine without apparent adverse interaction. For short-term pain management, an initial i.m. ketorolac tromethamine loading dose of 30 or 60 mg is recommended. Ketorolac tromethamine appears to be as effective as morphine or meperidine for short-term management of moderate to severe postoperative pain. It lacks the respiratory depressant effects of opiate analgesics but shares the toxic potentials of other NSAIAs.  相似文献   

7.
Seventy-five patients with moderate to severe cancer pain were randomly assigned in a double-blind fashion to receive first-dose ketorolac tromethamine 10 mg orally, acetaminophen 600 mg plus codeine 60 mg orally, or placebo, followed by subsequent doses of ketorolac or acetaminophen plus codeine four times daily for 7 days. Patient characteristics were similar among the treatment groups. The first-dose observation documented that both ketorolac and acetaminophen plus codeine produced an equivalent reduction in cancer pain and were superior to placebo as measured by pain intensity differences and pain relief. Multidose comparison documented a small but statistically significant advantage in mean daily pain relief favoring acetaminophen plus codeine, although there were no differences in mean daily ratings of overall effects for either study medication. Adverse symptoms were acceptable with both ketorolac and acetaminophen plus codeine. We conclude that ketorolac has significant analgesic activity in patients with cancer pain, although its precise role in the treatment regimen of these patients remains undefined.  相似文献   

8.
Study Objective . To compare the analgesic efficacy of ketorolac, ibuprofen-paracetamol (acetaminophen), and dextropropoxyphene-paracetamol in postoperative pain. Design . Randomized, double-blind, parallel, single-dose study. Setting . Multicenter, with five centers participating. Patients . One hundred sixty patients with moderate to severe postoperative pain requiring oral analgesics were enrolled. Seventeen patients were excluded from final analysis due to deviation from protocol. Interventions . Ketorolac tromethamine 10 mg, a combination of ibuprofen 400 mg plus paracetamol 325 mg, or a combination of dextropropoxyphene 65 mg plus paracetamol 400 mg was given orally to patients with moderate to severe baseline pain. Measurements and Main Results . Pain intensity and pain relief scores were rated at baseline, at 30 minutes, and hourly to 6 hours. Until the end of first hour, analgesia was similar for all three regimens. Ketorolac had a significantly higher analgesic effect than the two combinations between hours 2 and 6. Analgesia was similar for the two combinations. For all three test drugs the frequency of adverse effects was similar. Conclusions . Ketorolac 10 mg is a superior analgesic to ibuprofen-paracetamol or dextropropoxyphene-paracetamol in the treatment of postoperative pain.  相似文献   

9.
目的探讨静脉注射小剂量酮咯酸氨丁三醇联合间苯三酚解除肾绞痛的临床疗效。方法将140例肾绞痛患者随机分为三组,I组46例静脉注射酮咯酸氨丁三醇30mg,II组47例肌注酮咯酸氨丁三醇60mg,同时两组均静脉滴注间苯三酚80mg;III组47例在肌注哌替啶100mg的同时静脉滴注山莨菪碱10mg,观察比较各组给药后10、20、40min的疼痛缓解效果、不良反应等情况。结果给药后10minI组患者疼痛解除率及总有效率(19.56%,76.9%)明显高于Ⅱ组(0,40.42%)、III组(8.51%,55.31%),差异有统计学意义(P=0.005,P=0.002),给药后40min各组间比较差异无统计学意义(P=0.861,P=0.869);I组患者的平均疼痛解除时间为(14.3±9.5)min,短于Ⅱ组(23.8±5.4)min、Ⅲ组(18.2±8.3)min,差异有统计学意义(F=46.32,P〈0.05);I、Ⅱ组的不良反应率(8.69%,14.89%)低于Ⅲ组(82.97%),差异有统计学意义(P=0.000)。结论小剂量(30mg)酮咯酸氨丁三醇静脉注射联合间苯三酚静脉滴注对肾绞痛疗效好,起效快,不良反应少。  相似文献   

10.
目的 回顾性分析比较地佐辛与酮咯酸氨丁三醇在颈髓过伸伤中不同疼痛程度的患者的镇痛效果,指导合理选择镇痛药物. 方法 回顾性分析2012年12月至2015年12月解放军第98医院80例颈髓过伸伤出现痛觉过敏患者的病历资料,以长海痛尺评分评定患者疼痛程度,长海痛尺评分≥3分为用药指征,随机分为观察组和对照组,观察组给于地佐辛7.5mg肌注,对照组给于酮咯酸氨丁三醇60mg肌注,比较2组对于不同疼痛程度患者用药后疼痛评分情况,3分以下为有效,≥3分为无效镇痛,并观察2组用药后发生的不良反应情况. 结果 从镇痛有效率比较,2组用药30min后,中重度疼痛,观察组有效率100.0%,对照组有效率94.7%,差异无统计学意义(P>0.05),均为有效镇痛.剧烈以上疼痛,观察组镇痛有效率95.0%,对照组有效率仅为42.9%,差异有统计学意义(P<0.01),地佐辛镇痛效果优于酮咯酸氨丁三醇.从镇痛前后疼痛评分比较,2组在中重度疼痛镇痛后评分差异无统计学意义(P>0.05);观察组与对照组剧烈以上疼痛镇痛后评分分别为(1.32±0.99)、(3.40±2.20),差异有统计学意义(P<0.05).观察组药品不良反应发生率(20.0%)高于对照组(7.5%),差异有统计学意义(P<0.05). 结论 在颈髓过伸伤的镇痛治疗中,中重度疼痛可选择地佐辛或酮咯酸氨丁三醇,剧烈以上疼痛地佐辛镇痛效果明显优于酮咯酸氨丁三醇,但地佐辛不良反应率较高,因此临床用药上建议根据疼痛评分来合理选择镇痛药.  相似文献   

11.
目的:探讨酮咯酸氨丁三醇对鼻内镜下鼻窦手术术后早期疼痛的预防效果及安全性。方法:取60例择期行鼻内镜下鼻窦手术成年患者,随机分为酮咯酸组和芬太尼组,均采取全凭静脉麻醉,于雷米芬太尼停止泵入前15min分别静脉予以酮咯酸氨丁三醇30mg或芬太尼50μg,观察术后疼痛及出血情况。结果:两组患者术后疼痛(30min 3.2±1.3vs 3.4±1.5,60min 2.0±1.1vs2.8±2)及出血情况(鼻出血VAS评分6.6±3.1VS 5.1±3.1,痰中带血VAS评分3.1±1.8vs 3.4±1.8,更换敷料VAS评分5.2±3.5vs 4.3±3.4)差异均无统计学意义。结论:手术结束前静脉给予酮咯酸氨丁三醇可以较好的替代麻醉性镇痛药用于预防鼻内镜下鼻窦手术的成年患者术后镇痛而不增加术后出血风险。  相似文献   

12.
目的 建立酮咯酸氨丁三醇注射液的药物利用评价标准,并评价酮咯酸氨丁三醇注射液临床用药情况。方法 以药物说明书为基础,参照相关规范和专家共识,建立酮咯酸氨丁三醇注射液药物利用评价标准,采用回顾性研究方法,对我院2019年1月-3月50例使用酮咯酸氨丁三醇注射液的病历进行合理性评价。结果 用药指征符合率为80%,用法用量正确率为18%,疗程合理率为54%,联合用药合理率为40%,结论我院酮咯酸氨丁三醇注射液使用合格率较低,需近一步规范用药,确保患者用药的安全性。  相似文献   

13.
Study Objective . To compare the analgesic efficacy and safety of two single doses of ketorolac with diclofenac in acute cancer pain. Design . Double-blind, randomized, clinical study. Setting . Hospital-based clinical research center. Subjects . One hundred eighty patients suffering acute, moderate, or severe cancer pain. Interventions . A single intramuscular injection of ketorolac 10 or 30 mg or diclofenac 75 mg. Measurements and Main Results . Pain intensity was assessed 30 minutes and 1, 2, 3, 4, 5, and 6 hours after injection or until rescue drug administration. In approximately 70% of patients all treatments provided prompt sustained pain relief throughout the 6-hour observation period. There were no statistically significant differences in any of the analyzed efficacy measures among the three groups. Conclusion . Intramuscular ketorolac 10 mg is adequate to relieve cancer pain, and is equivalent to ketorolac 30 mg and to diclofenac 75 mg.  相似文献   

14.
In a double-blind, placebo-controlled study the efficacy and safety of topical ketorolac tromethamine were assessed in the reduction of inflammation and pain due to ankle sprain. Ketorolac 2% gel was compared with etofenamate and placebo (ketorolac vehicle) in a 15-day study. Patients attended for visits on days 1 (admission), 2, 3, 4, 8, and 15 of the study. Measurements of efficacy were ankle volume, pain measured on visual analogue scales (VAS) and verbal rating of pain. Safety was assessed by volunteered adverse events and vital signs. A total of 37 patients was admitted to the study of whom 13 received ketorolac, 12 placebo, and 12 etofenamate. One patient receiving ketorolac was lost to follow-up on day 15 owing to an unrelated accident. The remaining 36 patients completed the study. Ketorolac was significantly better than placebo in reducing the volume of the injured ankle based on the maximum, the area under the curve, and the day 15 percentage changes in ankle volume. Results for etofenamate were similar to those for ketorolac for all three variables and there were no significant differences between the active treatments. Reductions in VAS pain at rest were more marked in the ketorolac group than either of the other groups at all visits. On day 4 the differences between ketorolac and each of the other groups were statistically significant. Reductions in VAS pain on movement were also greatest for the ketorolac group at all visits. The differences between ketorolac and each of the other groups achieved statistical significance on days 4 and 8, but were marginal in terms of significance on day 2.(ABSTRACT TRUNCATED AT 250 WORDS)  相似文献   

15.
16.
The efficacy of a single dose of intramuscular ketorolac 10 mg or 90 mg was compared with pethidine 100 mg in a randomized double-blind study in 121 patients reporting at least moderate pain due to renal colic. Pain was assessed before drug administration, and then at 1 hour and 12 hours after the dose. Sedation was also assessed at these times, and additionally at the 12 hour assessment the time of the next analgesic dose was recorded. At 1 hour after dosing, pain scores had decreased in all groups; the largest decrease was seen in the ketorolac 90 mg group. The difference in the decrease was significant between the two ketorolac groups, but the differences between ketorolac and pethidine were not significant. Fewer patients in the ketorolac 90 mg group (17%) required a further dose of analgesic within 10 hours than in either the ketorolac 10 mg group (39%) or the pethidine 100 mg group (47%). The difference between ketorolac 90 mg and pethidine 100 mg was statistically significant. At both assessment times the proportion of patients with no sedation was higher in the two ketorolac groups than in the pethidine group. The overall incidence of adverse events was low with all drugs, notably so for the occurrence of vomiting after ketorolac. The results of the study show that intramuscular ketorolac is efficacious in the treatment of renal colic.  相似文献   

17.
Ketorolac versus aspirin for postpartum uterine pain   总被引:1,自引:0,他引:1  
Ketorolac tromethamine, a new nonsteroidal antiinflammatory analgesic, was evaluated for relative efficacy, safety and time course of analgesia in a stratified, randomized, parallel, double-blind trial. The study involved 120 hospitalized women (4 groups of 30) with moderate or severe postpartum uterine pain treated with single oral doses of ketorolac 5 mg and 10 mg, aspirin 650 mg or placebo. At regular interviews for 6 hours patients rated pain intensity, pain relief and side effects. Significant differences (p less than or equal to 0.05, two-tailed) occurred among the 4 treatments for various measurements of summed and peak analgesia. Ketorolac 10 mg was significantly superior to placebo in 5 of 5 major efficacy measurements, and aspirin was significantly superior in 3 of 5. Ketorolac 10 mg gave the highest mean rating for summed pain intensity differences (13.6, p = 0.0002 versus placebo), followed by aspirin (11.9, p = 0.012), ketorolac 5 mg (10.9, p = 0.072) and placebo (8.6). With ketorolac 10 mg and 5 mg and aspirin, analgesia lasted 6 hours, with peak efficacy at 3 hours. Side effects were not significant. Our results suggested a positive dose-response relationship for ketorolac. Compared to aspirin, ketorolac 10 mg induced equal or more analgesia, whereas ketorolac 5 mg was near the minimum effective dose and seemed less effective than aspirin.  相似文献   

18.
Patients who experienced pain after surgery were administered a single dose of 1 of 3 treatments: acetaminophen 1000 mg, codeine phosphate 60 mg, or a combination of these. Patients rated their pain intensity on ordinal and visual analog scales just prior to medication and at intervals thereafter for up to 5 hours. They also rated pain relief, pain half gone, and any adverse effects. Sum of pain intensity difference and total pain relief scores were analyzed using Dunnett's procedure. The drug combination was statistically superior to codeine as measured by SPID, TOTPAR, pain half gone, and time to remedication. The combination achieved better mean scores than acetaminophen on all efficacy measures, but was (marginally) statistically superior only in pain half gone. No appreciable differences in adverse effects were noted among the treatments. The difficulty of showing the analgesic efficacy of codeine in a single dose trial is discussed.  相似文献   

19.
Quadir M  Zia H  Needham TE 《Drug delivery》2000,7(4):223-229
Ketorolac tromethamine is a potent non-narcotic analgesic with moderate anti-inflammatory activity. Clinical studies indicate that ketorolac has a single dose efficacy greater than morphine for postoperative pain and has excellent applicability in the emergency treatment of pain. Due to incomplete oral absorption of ketorolac, several approaches have been tried to develop a nonoral formulation in addition to injections, especially for the treatment of migraine headache. The aim of our study was to develop a nasal formulation of ketorolac with a dose equivalent to the oral formulation. A series of spray and lyophilized powder formulations of ketorolac were administered into the nasal cavity of rabbits, and their pharmacokinetics profiles were assessed. The spray and powder formulations were compared through their pharmacokinetics parameters and absolute bioavailability. Drug plasma concentration was determined using solid phase extraction, followed by an HPLC analysis. Nasal spray formulations were significantly better absorbed than powder formulations. A nasal spray formulation of ketorolac tromethamine showed the highest absorption with an absolute bioavailability of 91%. Within 30 min of administration, the plasma concentration was comparable to that resulting from an intravenous injection. The absolute bioavailability of a solution of ketorolac acid was 70%. Apparently, the dissolution of ketorolac acid into the mucous layer limits its absorption. There were no significant differences in absorption between different powder formulations. Even the reduction of particle size from 123 θ m to 63 θ m did not indicate better absorption of ketorolac tromethamine from powder formulations. Interestingly, the absolute bioavailability of ketorolac tromethamine from a powder formulation is only 38%, indicating that the drug may not be totally released from the polymer matrix before it is removed from nasal epithelium by mucociliary clearance.  相似文献   

20.
Ketorolac tromethamine is a potent non-narcotic analgesic with moderate anti-inflammatory activity. Clinical studies indicate that ketorolac has a single dose efficacy greater than morphine for postoperative pain and has excellent applicability in the emergency treatment of pain. Due to incomplete oral absorption of ketorolac, several approaches have been tried to develop a nonoral formulation in addition to injections, especially for the treatment of migraine headache. The aim of our study was to develop a nasal formulation of ketorolac with a dose equivalent to the oral formulation. A series of spray and lyophilized powder formulations of ketorolac were administered into the nasal cavity of rabbits, and their pharmacokinetics profiles were assessed. The spray and powder formulations were compared through their pharmacokinetics parameters and absolute bioavailability. Drug plasma concentration was determined using solid phase extraction, followed by an HPLC analysis. Nasal spray formulations were significantly better absorbed than powder formulations. A nasal spray formulation of ketorolac tromethamine showed the highest absorption with an absolute bioavailability of 91%. Within 30 min of administration, the plasma concentration was comparable to that resulting from an intravenous injection. The absolute bioavailability of a solution of ketorolac acid was 70%. Apparently, the dissolution of ketorolac acid into the mucous layer limits its absorption. There were no significant differences in absorption between different powder formulations. Even the reduction of particle size from 123 θ m to 63 θ m did not indicate better absorption of ketorolac tromethamine from powder formulations. Interestingly, the absolute bioavailability of ketorolac tromethamine from a powder formulation is only 38%, indicating that the drug may not be totally released from the polymer matrix before it is removed from nasal epithelium by mucociliary clearance.  相似文献   

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