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1.
Antiemetics are commonly prescribed as prophylaxis for nausea and vomiting when opiate analgesics are prescribed in the emergency department. This prospective, randomized, double-blind, placebo-controlled trial assessed the incidence of nausea and vomiting after morphine and pethidine (meperidine) analgesia, and the effect of metoclopramide on this incidence. Intravenous morphine or pethidine analgesia was administered with metoclopramide or placebo to 122 opiate-na?ve patients with acute severe pain. Seven patients (5.7%) experienced nausea, three in the metoclopramide group and four in the placebo group. One patient (0.8%) had vomiting. The frequency of other side effects was higher in the metoclopramide group (7.9% versus 3.4%). None of these differences reached statistical significance. The low incidence of nausea and vomiting after opiate analgesia, and higher incidence of side effects with metoclopramide, are consistent with controlled data in the literature. Prophylactic metoclopramide should not be used routinely in ED patients receiving parenteral morphine or pethidine analgesia.  相似文献   

2.

Objective

The aim of this study was to compare the incidence of nausea and vomiting in patients with acute pain treated with morphine along with prophylactic metoclopramide or placebo.

Method

A randomised controlled trial was carried out on patients requiring morphine for acute pain in the emergency department (ED) setting. Children under the age of 12, patients who had been vomiting or had already received prehospital analgesia, and those unable to give consent were excluded. All patients were given either metoclopramide (10 mg) or placebo (normal saline) followed by intravenous morphine. Pain scores (measured on a visual analogue scale) before and after morphine administration, all incidents of nausea or vomiting, the dose of morphine, and the patients'' demographic data were recorded. Fisher''s exact test was used for comparing the two groups of patients.

Results

A total of 259 patients were recruited. There were 123 patients in the metoclopramide group (age range 15–94 years; median age 53) and 136 patients in the placebo group (age range 17–93 years; median age 52.5). The overall incidence of nausea and vomiting in the whole study population was 2.7%, (1.6% in the metoclopramide group and 3.7% in the placebo group). The difference between the two groups was not statistically significant (Fisher''s exact test = 0.451; p = 0.3; z‐test statistic = 1.02; 95% CI –6% to 2%).

Conclusion

When intravenous morphine is administered for acute pain, the overall incidence of nausea and vomiting is low, regardless of whether these patients are given prophylactic metoclopramide or not.  相似文献   

3.
The objective of the present study was to conduct a systematic review and meta‐analysis of randomized controlled trials, comparing metoclopramide with placebo, for preventing vomiting in patients who have received i.v. morphine for acute pain in the emergency setting, and to determine the level of evidence supporting the use of prophylactic metoclopramide in this population. Comprehensive systematic electronic searches were conducted of MEDLINE, EMBASE and the Cochrane Library for randomized controlled trials addressing the clinical question. Reference lists of identified articles were hand‐searched. Methodologically appropriate clinical trials identified in the search process were included in a meta‐analysis to provide a pooled estimate of effect. Three randomized controlled trials fulfilled the search criteria. All three studies were included in the final meta‐analysis that demonstrated an overall result of no difference between metoclopramide and placebo for the primary outcome of vomiting (odds ratios 0.72; 95% confidence intervals 0.11–4.58). There was little evidence that routine prophylactic administration of metoclopramide following the administration of i.v. morphine for acute pain management in the emergency setting is clinically beneficial. Routine metoclopramide administration might expose patients to a risk of harm, which is not justifiable given a lack of evidence of benefit.  相似文献   

4.
OBJECTIVE: To determine whether metoclopramide prevents nosocomial pneumonia in intensive care unit (ICU) patients receiving enteral feeding by a nasogastric tube. DESIGN: Prospective, randomized, controlled trial. SETTING: ICU of a university hospital. PATIENTS: A total of 305 consecutive patients requiring placement of a nasogastric tube for >24 hrs. INTERVENTIONS: Patients were randomized to receive either 10 mg of metoclopramide or placebo at 8-hr intervals through the nasogastric tube. MEASUREMENTS AND MAIN RESULTS: A total of 174 patients received placebo and 131 received metoclopramide. Baseline characteristics in the two treatment groups were comparable. Of the 305 patients, 46 developed nosocomial pneumonia, which was 24 patients (13.7%) in the placebo group and 22 (16.8%) in the metoclopramide group (p > .05). Patients in the placebo group developed pneumonia earlier than patients receiving metoclopramide (4.46+/-1.72 days [mean +/- SD[rsqb] after ICU admission compared with 5.95+/-1.78 days; p = .006). Subgroup analysis showed that metoclopramide did not reduce the frequency rate of pneumonia in patients with tracheal intubation (19 [25.3%] of 75 patients receiving metoclopramide vs. 21 [21.2%] of 99 patients receiving placebo) or those receiving mechanical ventilation (17 [25.6%] of 58 patients receiving metoclopramide vs. 20 [29.3%] of 78 patients receiving placebo). The mortality rate also did not differ in the two treatments groups (56% in the metoclopramide group vs. 53% in the placebo group; p > .05). CONCLUSIONS: Although metoclopramide delayed the development of nosocomial pneumonia, it did not decrease its frequency rate and had no effect on the mortality rate in critically ill patients receiving nasogastric enteral feeding.  相似文献   

5.
Vomiting of gastric contents is common among multisystem trauma patients and may cause significant morbidity. A study was conducted to examine whether metoclopramide (Reglan), an antiemetic and promotility agent, could decrease vomiting after administration of oral radiographic contrast in stable multisystem trauma patients undergoing computed tomography (CT) of the abdomen (“trauma CT patients”). The charts of 193 patients listed in the Duke Trauma Registry who underwent abdominal CT scanning from January, 1992 until February, 1993 were reviewed. The emergency department record was reviewed for documentation of vomiting, use of intravenous metoclopramide, and other potential confounders of vomiting such as age, pharmacologic paralysis, and head injury as measured by the Glasgow Coma Scale (GCS). Patients who received intravenous metoclopramide were six times less likely to vomit after administration of oral radiographic contrast than those who did not receive the drug. This effect increased to a twelvefold protective effect after correcting for age, pharmacologic paralysis, and GCS. These preliminary findings strongly suggest that routine use of metoclopramide may prevent vomiting of gastric contents after administration of oral radiographic contrast in trauma CT patients. A future prospective study is recommended to confirm these results.  相似文献   

6.
Objective: To determine the effect of the metoclopramide dose on the prevention of vomiting of N-acetylcysteine in acetaminophen overdose. Methods: Patients with acetaminophen ingestions receiving metoclopramide prior to emergency department administration of N-acetylcysteine were included. Emergency Department and poison center records were reviewed for administration of metoclopramide pre-N-acetylcysteine and incidence of subsequent vomiting. The treatment group was defined as patients receiving high-dose metoclopramide (20–50 mg intravenously) prior to the loading dose of N-acetylcysteine. Controls were patients receiving standard-dose (<20 mg intravenously) metoclopramide prior to loading dose of N-acetylcysteine. Outcome was vomiting within 60 minutes of N-acetylcysteine administration. Results: Twelve of 19 patients (63%) receiving standard-dose metoclopramide vomited N-acetylcysteine. Only 5 of 23 patients (22%) receiving high-dose metoclopramide vomited N-acetylcysteine (crude odds ratio: 6.2; 95% CI [1.3–30.3]). After controlling for confounding in the logistic regression model, the effect of high-dose metoclopramide in preventing vomiting of N-acetylcysteine remained significant (adjusted odds ratio: 17.0; 95% CI [2.6–110.0]). Conclusion: This study supports the efficacy of high-dose metoclopramide to prevent emesis after the oral loading dose of N-acetylcysteine.  相似文献   

7.
Background: Extended‐release epidural morphine (EREM) is an effective option for postoperative analgesia following major orthopedic surgery; however, postoperative nausea/vomiting (PONV) is a recognized limitation. The incidence of PONV following prophylactic aprepitant, a neurokinin‐1 antagonist, was compared with prophylactic multimodal antiemetic therapy in patients receiving EREM for postoperative analgesia following unilateral primary total knee arthroplasty (TKA). Methods: Prospectively collected quality assurance data were examined with Institutional Review Board approval. A sequential, open‐label, active matched case‐control study compared PONV following EREM in patients receiving ondansetron and dexamethasone, and either metoclopramide, diphenhydramine, or prochlorperazine every 6 hours for the 48‐hour study period, to patients receiving aprepitant 40 mg given as a single oral dose in the preoperative holding area. Cases were matched for procedure (TKA), age, epidural morphine dose, and known major risk factors for PONV (sex, smoking, previous PONV/motion sickness). Results: Twelve consecutive patients (3 male; 9 female) receiving aprepitant prior to EREM were matched to 12 patients of the same sex of similar age (range 51 to 84 years.) and EREM dose (range 5 to 12.5 mg) receiving the multimodal regime. The incidence of PONV was significantly less for the aprepitant group where 3 of 12 (25%) had PONV compared with 9 of 12 (75%) in the multimodal group (P = 0.039, Fisher's Exact Test; odds ratio = 0.11; 95% CI: 0.018 to 0.706, P = 0.03). Conclusion: While aprepitant significantly reduced the incidence of PONV compared with a multimodal antiemetic regime, used alone it did not eliminate PONV.  相似文献   

8.
Objective: To investigate the effect of the rate of metoclopramide infusion on akathisia incidence, severity, onset of symptoms, and duration in patients with headache, and/or nausea/vomiting in the emergency department (ED) setting. Methods: Prospective, double blind, randomised clinical study comparing two rates of intravenous infusion of metoclopramide over a period of six months at a tertiary university hospital ED. Results: A total of 300 patients presented to the ED met the inclusion criteria: 151 (50.3%) with nausea/vomiting, 108 (36%) with headache, and 41 (13.7%) with headache and nausea/vomiting. Of these, 154 patients (51.3%) were given 10 mg metoclopramide as a slow intravenous infusion over 15 minutes plus placebo (SIG group) and 146 patients were given 10 mg metoclopramide intravenous bolus infusion over two minutes plus placebo (BIG group). Nine of the 154 patients in the SIG group (5.8%) had akathisia compared with 36/146 patients (24.7%) in the BIG group (p<0.001, OR 5.273, 95% CI 2.43 to 11.403). Severe akathisia were observed in 13/45 (28.8%). The incidence of severe akathisia was significantly higher in the BIG group (30.5%; 11/36) than in the SIG group (22.2%; 2/9), p = 0.009. Metoclopramide successfully relieved the presenting symptom(s) of 137/146 (90.8%) and 139/154 (90.2%) patients in the BIG and SIG groups, respectively. Conclusions: This study suggests that slowing the rate of infusion of metoclopramide is an effective strategy for reducing the incidence of akathisia in patients with headache, and/or nausea/vomiting in ED.  相似文献   

9.
Background: The efficacy of non‐narcotic analgesics is mostly supported by randomized, placebo‐controlled trials with no comparison with ordinary practice. Additionally, systematic reviews of these placebo‐controlled trials have failed to determine clinically meaningful dose–response effect. Methods: In this double‐blind, randomized trial, patients undergoing elective inguinal, umbilical or epigastric herniorrhaphy under general anesthesia were assigned to receive 15 mg/kg (D15 group) vs. 40 mg/kg (D40 group) of dipyrone intravenously during surgery. The primary outcome was the incidence of moderate to severe pain with movement during the recovery room phase. The secondary outcomes were morphine consumption, incidence of vomiting, and Ramsay score (sedation scale). Results: One hundred sixty‐two patients were enrolled and analyzed for the primary and secondary outcomes. Relative to the D15 group, the D40 group showed a lower incidence of moderate to severe pain in the first 30 minutes (61% and 40%; P value < 0.05); lower cumulative morphine consumption during the recovery period (3.85 vs. 2.55 mg, P value < 0.006) as well as a lower incidence of vomiting (15.8% vs. 2.5%, P value < 0.005). In addition, more cases of sedation were recorded in the D15 group than in the D40 group (17 vs. 10 cases). There were no serious adverse effects attributed to dipyrone in either group. Conclusion: This trial shows a dose–response effect of 40 mg/kg over 15 mg/kg of intravenous dipyrone based on better movement‐induced pain control, lower morphine consumption and fewer opioid‐related side effects.  相似文献   

10.
OBJECTIVE: To determine if systematic use of metoclopramide associated with opioids (Morphine sulfate SR) decreases the incidence of nausea and vomiting (N&V), established adverse effects of opioids. METHOD: Open randomised study with 132 patients treated for non malignant pain (71 women, 61 men, mean age 53.4 years). One group (n = 76) was treated with morphine alone; the other (n = 56) with morphine plus metoclopramide. Mean duration of therapy: 6 days; mean dosage: 60 mg/d RESULTS: In the 2 groups, N&V were present in the first 72 hours. The frequency of N&V in the morphine group was 38.1% (conform with the literature). The systematic use of metoclopramide decreases the frequency of N&V: p < 0.005. However the use of morphine > 60 mg/d decreases N&V: p = 0.036. High dosages of morphine can have an antiemetic effect by interaction with the mu receptors in the antiemetic center and not in the trigger zone which has an emetic effect. CONCLUSION: The systematic use of metoclopramide with opioid therapy for non malignant pain in rheumatology decreases the risk of nausea and vomiting.  相似文献   

11.
Background: The aim was to investigate whether children experience less fear, distress, and/or pain when they receive oral morphine vs. placebo before a needle is inserted in a subcutaneously implanted intravenous port when combined with topical anesthesia. Method: Fifty children 1–18 years of age who were treated in a pediatric oncology and hematology setting were included consecutively when undergoing routine needle insertion into an intravenous port. All children were subjected to one needle insertion following topical anesthetic (EMLA) application in this randomized, triple‐blind, placebo‐controlled study comparing orally administered morphine (n= 26) 0.25 mg/kg body weight with placebo (n= 24). The patients’ fear, distress, and pain were reported by parents, nurses and the children themselves (if ≥7 years of age) on 0–100 mm Visual Analogue Scales. In addition, observational methods were used to measure distress and procedure pain. Results: No differences between the morphine and the placebo group were found with respect to age, weight, height, physical status, sex, weeks from diagnosis, or weeks from latest needle insertion. According to, parents, nurses, and children, oral morphine at a dose of 0.25 mg/kg body weight did not reduce fear, distress or pain compared with placebo. Conclusion: We could not reject the null hypothesis that there is no difference between the oral morphine and placebo groups assuming an effect size of 15 mm on VAS. Therefore it seems that oral morphine at 0.25 mg/kg does not give any additional reduction of fear, distress or pain compared with placebo when combined with topical anesthesia in pediatric patients undergoing subcutaneous port needle insertion, and would not be expected to be of any advantage for similar procedures such as venipuncture and venous cannulation when topical anesthesia is used.  相似文献   

12.
Two double-blind, placebo-controlled, prospective randomized trials in the emergency department (ED) setting have examined the use of metoclopramide for the prevention of opiate-induced nausea and vomiting. Both showed a low incidence of vomiting in the control group. This prospective observational study in 205 unselected ED patients with acute pain syndromes measured nausea and vomiting before intravenous opiate administration and 30 and 60 minutes posttreatment. Cumulative incidence of vomiting was 1.5% at 30 minutes and 2.4% at 60 minutes. Corresponding figures for nausea were 4.9% at 30 minutes and 9.3% at 60 minutes, with more than 75% of patients rating their nausea as mild. Prevalence of both nausea and vomiting were higher at baseline than after analgesia. These data support the findings of previous randomized trials that the incidence of nausea and vomiting after intravenous opiate analgesia in the ED is low and argues against routine use of prophylactic antiemetic administration in combination with opiate analgesia.  相似文献   

13.
Opposing effects of ondansetron and tramadol on the serotonin pathway have been suggested which possibly increase tramadol consumption and emesis when co-administered. In a randomized, double-blinded study, 179 patients received intravenous ondansetron, metoclopramide, or placebo for emesis prophylaxis. Analgesic regimen consisted of tramadol intraoperative loading and subsequent patient-controlled analgesia. Tramadol consumption and response to antiemetic treatment were compared. Additionally, plasma concentrations of ondansetron and (+)O-demethyltramadol and CYP2D6 genetic variants were analyzed as possible confounders influencing analgesic and antiemetic efficacy. Tramadol consumption did not differ between the groups. Response rate to antiemetic prophylaxis was superior in patients receiving ondansetron (85.0%) compared with placebo (66.7%, P = .046), with no difference to metoclopramide (69.5%). Less vomiting was reported in the immediate postoperative hours in the verum groups (ondansetron 5.0%, metoclopramide 5.1%) compared with placebo (18.6%; P = .01). Whereas plasma concentrations of (+)O-demethyltramadol were significantly correlated to CYP2D6 genotype, no influence was detected for ondansetron. Co-administration of ondansetron neither increased tramadol consumption nor frequency of PONV in this postoperative setting.  相似文献   

14.
Although combination antiemetics prevent vomiting during the initial 24 h after high-dose (≥100 mg/m2) cisplatin, many patients experience delayed emesis 24–120 h afterwards despite receiving prophylactic dexamethasone and metoclopramide during this time. Cisapride is a prokinetic agent, which stimulates propulsive motility throughout the gastrointestinal tract without causing extrapyramidal effects. In this phase II trial, we tested the ability of cisapride to prevent delayed emesis following cisplatin. Twenty patients receiving initial cisplatin ≥100 mg/m2 were entered. All patients received intravenous dexamethasone with either metoclopramide or ondansetron to prevent acute emesis 0–24 h after receiving cisplatin. Patients who had experienced two or fewer acute vomiting episodes then received cisapride 20 mg orally four times daily for 4 days (24–120 h after cisplatin). Cisapride prevented delayed emesis in 2 patients (10%) during the entire 4-day period (95% confidence interval, 1–32%). Abdominal cramping and pain occurred in 35%. At the dose and schedule tested, oral cisapride prevented delayed emesis in only 10% of patients receiving cisplatin ≥100 mg/m2 and caused abdominal cramping in 35%. Since in prior trials among similar patients, placebo prevented delayed emesis in 11%, further study of cisapride and dose escalation for this indication are not recommended.  相似文献   

15.
PROBLEM: Postoperative nausea and vomiting remains an important problem. Many risk factors have been identified; however, the importance of postoperative analgesic technique and patient expectation remain poorly defined. METHODS: We prospectively collected data on postoperative nausea and vomiting (PONV) in four groups of randomly selected patients (n=50 per group) who received either simple analgesics, nurse-administered intravenous morphine (NAA), patient-controlled analgesia (PCA) with morphine or epidural analgesia with bupivacaine and fentanyl. Patients were questioned regarding any past history of PONV or motion sickness, their preoperative expectation of suffering PONV and satisfaction with their antiemetic therapy. RESULTS: The incidence of nausea was higher in both morphine groups P<0.05), women (P<0.05), those less than the median age of their group (P<0.05) and those with a past history of PONV (P<0.05) or motion sickness (P<0.05). Most patients did not expect to experience PONV (19.3%). The incidence of nausea was higher in those expecting to experience PONV than in those not expecting to suffer PONV (P<0.01). Of those who received postoperative antiemetic treatment, 23.6% were dissatisfied or very dissatisfied with their therapy. Few patients received a prophylactic antiemetic drug (15%). CONCLUSIONS: Study results show that patient expectation is a potent predictor of postoperative nausea, a risk factor hitherto ignored in the anaesthetic literature, and that, in the provision of analgesia following major surgery, epidural analgesia is associated with less PONV than intravenous morphine.  相似文献   

16.
Nalmefene is a long-acting opioid antagonist that provides long-term relief from side effects of intrathecal morphine sulfate. A randomized, double-blind, placebo-controlled study was conducted to determine whether prophylactic nalmefene could decrease side effects of intrathecal morphine given during cesarean section, without affecting analgesia. Sixty parturients were given 0.25 mg of intrathecal morphine, 12.5 micrograms of fentanyl, and 11.25 to 15 mg of bupivacaine. A dose of 0.25 microgram/kg of nalmefene or placebo was given by intravenous piggyback immediately after delivery of the neonate. Nausea, vomiting, pruritis, and level of sedation were assessed for a 24-hour period using a 4-point ordinal scoring system. Pain was assessed by using a 0- to 10-point verbal analogue scale. A 5-point analgesic satisfaction survey also was completed. Subjects who received nalmefene required supplemental analgesia at a median of 6.00 hours after intrathecal morphine, compared with 14.12 hours in the placebo group (P = .037). No differences were found between the groups in the incidence of pruritis, nausea and vomiting, level of sedation, or analgesic satisfaction. We concluded that nalmefene at a dose of 0.25 microgram/kg does not decrease the incidence of side effects but increases the need for supplemental analgesics.  相似文献   

17.
目的 :研究地塞米松静脉给药与硬膜外给药对降低术后吗啡硬膜外镇痛恶心呕吐 (PONV)的作用是否存在不同。方法 :选择 15 0例硬膜外麻醉的妇科手术病例 ,随机分为 3组 ,手术结束前A组硬膜外腔注射 10mg地塞米松 ,B组静脉给予 10mg地塞米松 ,而C组不用地塞米松 (对照组 )。术毕所有病例均行吗啡联合小剂量氟哌利多硬膜外镇痛。观察 4 8h内恶心呕吐的发生率和严重程度 ,随访伤口感染或延迟愈合等情况。结果 :PONV发生率A组为 16 % ,B组为 8% ,两组无显著差异 (P >0 .0 5 ) ,均明显低于C组 (4 8% ) ,两组与C组相比均有显著差异 (P <0 .0 1)。未发生伤口感染或延迟愈合的病例。结论 :地塞米松10mg无论静脉给药还是硬膜外给药均能显著降低妇科手术后吗啡镇痛患者PONV的发生率 ,且单次给药无明显的不良反应  相似文献   

18.

Objective

We investigated the difference in incidence of acute akathisia related to the rate of infusion in patients receiving metoclopramide for acute nausea, vomiting, or migraine headache in the emergency department (ED).

Methods

Randomized, prospective, double-blind clinical trial of patients aged 18 years and older who were to receive intravenous metoclopramide for the treatment of nausea, vomiting, or headache were eligible. Patients were excluded if they were taking medications that might mimic or mask akathisia, had a movement disorder, renal insufficiency, or were unable or unwilling to consent. Pregnant women and prisoners were also excluded. Subjects were randomized to receive 1 of 2 accepted metoclopramide administration regimens. The regimens included 10 mg of metoclopramide administered either as a 2-minute bolus (BG) or as a slow infusion for 15 minutes (IG). All patients received a normal saline placebo at the opposite rate to maintain blinding. The main outcome was development of akathisia noted at 60 minutes after drug administration as measured either with The Prince Henry Hospital akathisia rating scale or by sudden unexplained departure from the ED during treatment.

Results

One hundred twenty-seven patients were eligible for the study. Fifty-nine patients met exclusion criteria. Of the remaining 68 patients, 36 were randomized to the BG and 32 were randomized to the IG. In the BG, 11.1% of patients developed akathisia compared with 0% in the IG (P = .026). Four patients developed akathisia based on the scale and 2 departed suddenly from the ED.

Conclusions

Slower infusion of metoclopramide reduces the incidence of akathisia.  相似文献   

19.
Background: Metoclopramide is commonly used to accelerate small bowel transit during barium follow-through (BaFT) examinations, but its action is unpredictable. Cisapride, commonly used to treat gastroesophageal reflux disease, also accelerates small bowel transit and may be a viable alternative. The two were compared in a prospective, randomized, blind study. Methods: Patients attending for BaFT were randomized to receive either 10 mg cisapride or 20 mg metoclopramide orally 1 h before the barium suspension. BaFT was performed by using a standard technique, and small bowel transit and study quality were compared. Patients also noted any side effects experienced. Results: Of 45 patients recruited, 27 received cisapride and 18 metoclopramide. Median transit time for the cisapride group was 30 min (range = 10–130 min) versus 67.5 min (range = 30–290 min) for the metoclopramide group (p= 0.019). Study quality was comparable. However, nine patients (33%) receiving cisapride experienced nausea versus only one subject (6%) receiving metoclopramide (p= 0.034). Conclusions: This study suggests that cisapride is a more effective prokinetic agent than metoclopramide, but this benefit is offset by a higher incidence of side effects. Received: 17 August 1999/Revision accepted: 3 November 1999  相似文献   

20.
OBJECTIVE: To determine the incidence of intravenous site reactions to phenytoin and valproate in a large population of patients with neurotrauma. DESIGN: Retrospective chart review of two double-blind, randomized clinical trials evaluating the use of antiepileptic drugs to prevent posttraumatic seizures in patients with neurotrauma: phenytoin versus placebo (n = 390), and valproate versus phenytoin with placebo (n = 385). Information collected from the charts included the number, type, and location of intravenous lines and intravenous site events. SETTING: Tertiary care trauma and university teaching hospital. MAIN RESULTS: Intravenous site reactions occurred in 18% and 25% of patients receiving valproate or phenytoin, respectively, with the majority of events (70%) occurring in the first intravenous site. Patients received the neurosurgery study drug (NSSD) by either central or peripheral lines; all intravenous site reactions occurred in peripheral administration sites. When patients who received the drug by central line during the course of therapy were excluded, the estimated incidence of site reactions was 21% and 30% for valproate and phenytoin, respectively (p = 0.056). The time to the first event was shorter with phenytoin compared with valproate (2.0 +/- 1.3 vs. 3.0 +/- 1.9 d; p = 0.009). Fewer adverse events were noted with phenytoin in the phenytoin-without-valproate study than in the phenytoin-with-valproate study, with 4.3% and 8.2% of intravenous site events recorded in patients receiving placebo or phenytoin, respectively. There was no significant difference in the number of intravenous lines per patient used during NSSD drug infusion for phenytoin versus placebo or phenytoin versus valproate. CONCLUSIONS: Both intravenous phenytoin and valproate resulted in intravenous site reactions, with the loading doses responsible for the majority of the events.  相似文献   

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