A randomized, double-blind comparison of granisetron alone and combined with dexamethasone for post-laparoscopic cholecystectomy emetic symptoms

Background

Granisetron hydrochloride, a selective serotonin receptor antagonist, has been used to treat established postoperative nausea and vomiting (PONV). Dexamethasone has been shown to reduce the incidence of chemotherapy-induced emesis when added to an antiemetic regimen.

Objective

The aim of this study was to examine the differences in efficacy and tolerability between the combination of granisetron plus dexamethasone and granisetron alone for the treatment of PONV.

Methods

This study was a randomized, double-blind trial conducted at Toride Kyodo General Hospital (Toride, Ibaraki, Japan). Men and women aged 25 to 65 years and experiencing emetic symptoms after laparoscopic cholecystectomy were eligible for the study. Patients received IV therapy with either granisetron 40 μg/kg alone or with dexamethasone 8 mg. Patients were observed for 24 hours. Emetic episodes and the need for a rescue antiemetic were recorded by nursing staff, who were blinded to treatment assignment.

Results

One hundred patients (63 women, 37 men; mean [SD] age, 47 [10] years; range, 25-65 years) were enrolled; 50 patients were randomized to each treatment group. No significant differences in baseline demographic or clinical characteristics were observed between the groups. Complete control of established PONV, defined as no emetic symptoms and no need for another rescue antiemetic medication, occurred in significantly more patients who received the combination (49/50 [98%]) than in those who received granisetron alone (41/50 [82%]) (P = 0.008). No clinically important adverse effects due to the study drugs were observed in either group.

Conclusion

In this study population of patients experiencing post-cholecystectomy emesis, the combination of granisetron plus dexamethasone was more efficacious than granisetron alone for the treatment of PONV. Tolerability between the 2 treatments was similar.     

Pain, depression, and fatigue as a symptom cluster in advanced cancer

Context

Pain, depression, and fatigue are common symptoms in cancer populations. They often coexist and have been suggested as a specific symptom cluster. Systemic inflammation (SI) may be a possible common mechanism.

Objective

This study examined whether pain, depression, and fatigue exist as a symptom cluster in advanced cancer patients with cachexia and might be related to the presence of SI.

Methods

Secondary data analysis was undertaken of two clinical trials in patients with cancer cachexia (n = 654). Pain, depression, and fatigue were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Plasma C-reactive protein (CRP) was measured as a marker of SI in a subgroup (n = 436). Multivariate analysis and a series of regression analyses were undertaken relating pain, depression, fatigue, and CRP.

Results

Pain, depression, and fatigue clustered, with between two and four times as many patients having all three symptoms as would be expected if the symptoms only coexist by chance (P < 0.001). CRP was not related to the symptom cluster. There was a strong relationship between the pattern of symptoms and physical functioning (P < 0.001).

Conclusion

Pain, depression, and fatigue is an identifiable symptom cluster in a cohort of cachexic cancer patients and is associated with reduced physical functioning.     

Global end-diastolic volume, serum osmolarity, and albumin are risk factors for increased extravascular lung water

Background

The transpulmonary thermodilution technique allows the determination of cardiac preload (global end-diastolic volume index) and quantification of pulmonary edema (extravascular lung water index [EVLWI]). Pulmonary edema commonly develops in critically ill patients; however, the underlying pathophysiology, that is, hydrostatic (cardiac) or permeability-induced (noncardiac), often remains unclear. In this study, hemodynamic and serum parameters of osmolarity and oncotic pressure were analyzed to identify risk factors for increased EVLWI.

Methods

A retrospective, single-center analysis in an intensive care unit of a university hospital was performed. No interventions were made for the study. Forty-two critically ill patients were included, and 126 simultaneous hemodynamic measurements and serum determinations were analyzed by logistic regression and Spearman rank correlation coefficient analysis.

Results

Global end-diastolic volume index (P = .001), serum albumin (P = .006), and serum osmolarity (P = .029) were significant factors for increased EVLWI (defined as >10 mL/kg).

Conclusion

Hypervolemia, hypoalbuminemia, and high plasma osmolarity are associated with increased EVLWI.     

Effects of zafirlukast on the function of humanpolymorphonuclear neutrophil leukocytes in asthmatic patients: A prospective, controlled, in vitro study

Background:

Reactive oxygen species (ROSS) play an important role in the pathogenesis of asthma, and oxidative stress contributes to the initiation and worsening of inflammatory respiratory disorders (eg, asthma). Thus, antioxidant drugs may have a role in reducing or preventing damage in asthma.

Objective:

The aim of the study was to investigate the antioxidant effect of zafirlukast, a leukotriene receptor antagonist, in asthma.

Methods:

This prospective, controlled, in vitro study was conducted at KingKhalid University Hospital, Riyadh, Saudi Arabia. The generation of ROSS by polymorphonuclear neutrophil leukocytes (PMNs) in patients with mild to moderate asthma (forced expiratory volume in 1 second [FEVI], >70% of the predicted value) and healthy volunteers was assessed using chemiluminescence (CL) with phorbol 12-myristate 13-acetate (PMA) and opsonized zymosan (OPZ) in the presence of different concentrations of zafirlukast (1.25-60 μg/mL). The xanthine/xanthine oxidase (X-XOD) reaction was used to test the scavenging effect of the drug.

Results:

Six asthmatic patients (4 women, 2 men; mean age, 30.8 years; meanFEVI, 82.5% of the predicted value) and 8 healthy volunteers (4 women, 4 men; mean age, 28.8 years) were enrolled. A dose-dependent inhibition of the CL response was observed in both groups. However, patients with asthma required higher concentrations of zafirlukast to achieve an inhibitory effect similar to that in healthy controls. This difference was significant at concentrations of 20 to 60 μg/mL (all, P ≤ 0.05). When PMNs were challenged with OPZ, inhibition was also dose dependent in controls at all concentrations (all, P ≤ 0.05), but the inhibitory effect was not significant in the asthmatic patients at any concentration. The difference in the inhibitory effect between the 2 groups was significant at 30, 40, and 60 μg/mL (P < 0.02, <0.01, and <0.01, respectively). The mean (SEM) viability of the PMNs in the healthy controls was significantly affected only at the highest concentration compared with the control saline dose (86.5% [5.8%] vs 97.0% [8.%]; P < 0.05). No scavenging effect of zafirlukast was found using the X XOD system. Incubating PMA-stimulated cells with zafirlukast (5 and 10 μg/mL) for 10 minutes to 1 hour significantly increased the inhibitory effect of the drug by 15% to 46% (all, P < 0.001). When zafirlukast was tested for reversibility of its inhibitory effect on ROS production, its action was found to be irreversible at a concentration of 30 μg/mL (P < 0.001) and partially reversible at 60 μg/mL compared with the baseline saline control.

Conclusions:

Zafirlukast inhibited ROS generation by PMNs in a dose-dependentmanner in asthmatic patients and healthy subjects. However, asthmatic patients required much higher concentrations compared with controls. The incubation of the stimulated cells with zafirlukast increased the inhibitory effect. This finding suggests that the therapeutic effect of zafirlukast in asthma may be in part related to its antioxidant action.     

Factor Structure and Predictive Validity of Somatic and Nonsomatic Symptoms From the Patient Health Questionnaire-9: A Longitudinal Study After Spinal Cord Injury

Krause JS, Reed KS, McArdle JJ. Factor structure and predictive validity of somatic and nonsomatic symptoms from the Patient Health Questionnaire-9: a longitudinal study after spinal cord injury.

Objective

To investigate the factor structure and predictive validity of somatic and nonsomatic depressive symptoms over the first 2.5 years after spinal cord injury (SCI) using the Patient Health Questionnaire-9 (PHQ-9).

Design

Somatic and nonsomatic symptoms were assessed at baseline during inpatient hospitalization (average of 50 days after onset) and during 2 follow-ups (average of 498 and 874 days after onset).

Setting

Data were collected at a specialty hospital in the Southeastern United States and analyzed at a medical university. We performed time-lag regression between inpatient baseline and follow-up somatic and nonsomatic latent factors of the PHQ-9.

Participants

Adults with traumatic SCI (N=584) entered the study during inpatient rehabilitation.

Interventions

Not applicable.

Main Outcome Measure

PHQ-9, a 9-item measure of depressive symptoms.

Results

The inpatient baseline nonsomatic latent factor was significantly predictive of the nonsomatic (r=.40; P=.000) and somatic latent factors at the second follow-up (r=.29; P=.006), whereas the somatic factor at inpatient baseline did not significantly predict either factor. In contrast, when regressing latent factors between the 2 follow-ups, the nonsomatic factor predicted only the nonsomatic factor (r=.66; P=.002), and the somatic factor predicted only future somatic symptoms (r=.66; P=.000). In addition, the factor structure was not stable over time. Item analysis verified the instability of somatic items between inpatient baseline and follow-up and also indicated that self-harm at inpatient baseline was highly predictive of future self-harm.

Conclusions

Nonsomatic symptoms are better predictors of future depressive symptoms when first assessed during inpatient rehabilitation, whereas somatic symptoms become stable predictors only after inpatient rehabilitation. Self-harm (suicidal ideation) is the most stable symptom over time. Clinicians should routinely assess for suicidal ideation and use nonsomatic symptoms when performing assessments during inpatient rehabilitation.     

Ultrasonographic Median Nerve Changes After a Wheelchair Sporting Event

Impink BG, Boninger ML, Walker H, Collinger JL, Niyonkuru C. Ultrasonographic median nerve changes after a wheelchair sporting event.

Objectives

To investigate the acute median nerve response to intense wheelchair propulsion by using ultrasonography and to examine the relationship between carpal tunnel syndrome (CTS) signs and symptoms and the acute median nerve response.

Design

Case series.

Setting

Research room at the National Veterans Wheelchair Games.

Participants

Manual wheelchair users (N=28) competing in wheelchair basketball.

Intervention

Ultrasound images collected before and after a wheelchair basketball game.

Main Outcome Measures

Median nerve cross-sectional area, flattening ratio, and swelling ratio and changes in these after activity. Comparison of median nerve characteristics and patient characteristics between participants with and without positive physical examination findings and with and without symptoms of CTS.

Results

Significant changes in median nerve ultrasound characteristics were noted after activity. The group as a whole showed a significant decrease in cross-sectional area at the radius of 4.05% (P=.023). Participants with positive physical examinations showed significantly different (P=.029) and opposite changes in swelling ratio compared with the normal group. Subjects with CTS symptoms had a significantly (P=.022) greater duration of wheelchair use (17.1y) compared with the asymptomatic participants (9y).

Conclusions

Manual wheelchair propulsion induces acute changes in median nerve characteristics that can be visualized by using ultrasound. Studying the acute median nerve response may be useful for optimizing various interventions, such as wheelchair set up or propulsion training, to decrease both acute and chronic median nerve damage and the likelihood of developing CTS.     

Spontaneous Rupture of the Spleen: A Rare but Serious Case of Acute Abdominal Pain in Pregnancy

Background

Spontaneous (non-traumatic) rupture of the spleen rarely occurs in the setting of a normal spleen, especially during pregnancy.

Objectives

We report a case of spontaneous rupture of a normal spleen at 33.7 weeks gestation and review the literature with the aim of exploring the etiology, diagnosis, and management of this condition during pregnancy.

Case Report

A 30-year-old Chinese primigravida presented at 33.7 weeks gestation with acute onset of severe, constant left upper abdominal pain. She developed acute hypotension. Physical examination revealed diffuse abdominal tenderness with rebounding and guarding. An emergent cesarean delivery and abdominal exploration was performed. A non-viable male infant was delivered, and active bleeding was identified at the splenic hilum consistent with splenic rupture. A splenectomy was performed, and a consumptive coagulopathy was identified and treated. The patient had an uncomplicated postoperative course and was discharged home on postoperative day 15.

Conclusion

Splenic rupture in pregnancy is a life-threatening complication. Early diagnosis and aggressive surgical intervention will allow for optimal maternal and perinatal outcome.     

Comparison of the effects of remifentanil andalfentanil on cardiovascular response to nasotracheal intubation: A prospective, randomized, double-blind study

Background:

Nasotracheal intubation is often necessary in patients undergoingelective or emergency maxillofacial surgery. Previous studies have suggested that the increase in blood pressure after nasotracheal intubation is significantly greater than the increase after orotracheal intubation. Many drugs, including narcotic analgesics, are effective in modifying cardiovascular responses to orotracheal intubation.

Objective:

The effects of remifentanil and alfentanil on the cardiovascularresponses to nasotracheal intubation were compared in healthy patients scheduled to undergo surgery.

Methods:

This prospective, randomized, double-blind study was conductedat the Department of Anesthesiology and Reanimation, Faculty of Medicine, Dicle University, Diyarbakir, Turkey. Patients aged 16 to 65 years scheduled to undergo elective maxillofacial surgery and who were American Society of Anesthesiologists status I or 11 were randomly assigned to receive remifentanil 1 μg/kg in 10 mL saline over 30 seconds followed by an infusion of 0.5 μg/kg · min, or alfentanil 10 μg/kg in 10 mL saline over 30 seconds followed by an infusion of saline. Anesthesia was then induced with propofol, cisatracurium, and 1% isoflurane with 66% nitrous oxide in oxygen. Heart rate (HR) and systolic and diastolic arterial pressures (SAP and DAP, respectively) were measured noninvasively at 2 minutes before general anesthesia induction (baseline); 2 minutes after induction; and 1, 3, and 5 minutes after nasotracheal intubation. Patients were monitored for cardiac changes using electrocardiography.

Results:

Forty consecutive patients were enrolled in the study. Twenty patients (11 males, 9 females; mean [SD] age, 27.7 [12.6] years) received remifentanil, and 20 patients (12 males, 8 females; mean [SD] age, 31.5 [17.2] years) received alfentanil. Two minutes after anesthesia induction, mean (SD) arterial pressures decreased significantly from baseline in the remifentanil group (changes, 22 [8]/11 [6] mm Hg) and the alfentanil group (changes, 10 [9]/12 [8] mm Hg) (both, P < 0.05). Changes in SAP and DAP followed a similar pattern in both groups, but SAP was significantly lower in the remifentanil group compared with that in the alfentanil group throughout the study period (all, P < 0.05). After 1 minute of intubation, DAP was significantly lower in the remifentanil group compared with that in the alfentanil group (66 [9] mm Hg vs. 73 [20] mm Hg; P < 0.05). Compared with baseline, HR was decreased significantly in both groups throughout the study (all, P < 0.05). Except SAP in the alfentanil group, SAP, DAP, and HR were increased 1 minute after intubation compared with preintubation values. However, SAP, DAP, and HR remained significantly lower compared with baseline values throughout the study period in both groups (all, P < 0.05) except DAP at 1 minute after incubation in the alfentanil group. Five patients in the remifentanil group and 2 patients in the alfentanil group required treatment of hypotension. None of the patients in either group required treatment of bradycardia.

Conclusions:

In this study in healthy surgical patients aged 16 to 65 years, remifentanil 1 μg/kg given over 30 seconds, followed by a remifentanil infusion of 0.5 μg/kg · min, was similarly effective compared with alfentanil 10 μg/kg in attenuating the pressor response to nasotracheal intubation, but the incidence of hypotension in patients administered remifentanil was high.     

Predictors of Success for Physiotherapy Treatment in Women With Persistent Postpartum Stress Urinary Incontinence

Dumoulin C, Bourbonnais D, Morin M, Gravel D, Lemieux M-C. Predictors of success for physiotherapy treatment in women with persistent postpartum stress urinary incontinence.

Objective

To identify predictors of success for physiotherapy treatment in women with persistent postpartum stress urinary incontinence (SUI).

Design

Secondary analysis of data from a single-blind randomized controlled trial comparing 2 physiotherapy intervention programs for persistent SUI in postpartum women.

Setting

Obstetric clinic of a mother and children's university hospital.

Participants

Women, ages 23 to 39 (N=57), were randomized to 1 of 2 pelvic floor muscle (PFM) training programs, 1 with and 1 without abdominal muscle training.

Intervention

Over 8 weeks, participants in each group followed a specific home exercise program once a day, 5 days a week. In addition, participants attended individual weekly physiotherapy sessions throughout the 8-week program.

Main Outcome Measures

Treatment success was defined as a pad weight gain of less than 2g on a 20-minute pad test with standardized bladder volume after 8 weeks' treatment. The relationship between potential predictive PFM function variables as measured by a PFM dynamometer and success of physiotherapy was studied using forward stepwise multivariate logistic regression analyses.

Results

Forty-two women (74%) were classified as treatment successes, and 15 (26%) were not. Treatment success was associated with lower pretreatment PFM passive force and greater PFM endurance pretreatment, but the latter association was barely statistically significant. This model explained between 23% (Cox and Snell R²) and 34% (Nagelkerke R²) of the outcome variability.

Conclusions

The results contribute new information on predictors of success for physiotherapy treatment in women with persistent postpartum SUI.     

Effects of single-dose injectable paracetamolversus propacetamol in pain management after minor gynecologic surgery: A multicenter, randomized, double-blind, active-controlled, two-parallel-group study

Background:

Intravenous administration is the route of choice for drug therapy in the immediate postoperative period. Propacetamol (ProAPAP), an injectable prodrug of paracetamol requiring reconstitution, has demonstrated efficacy in managing acute pain and fever. However, it has been associated with pain at the injection site. A stable, ready-to-use formulation of paracetamol solution infused intravenously (IV-APAP) has been developed and might be associated with less pain at the injection site compared with ProAPAR

Objective:

The objective of this study was to assess the tolerability and efficacy of a single dose of IV APAP 1 g compared with those of a single dose of ProAPAP 2 g in patients with moderate to severe pain after minor gynecologic surgery.

Methods:

This single-dose, randomized, double-blind, active-controlled,2-parallel-group study was conducted at 23 hospitals and outpatient clinics in France. After minor gynecologic surgery, patients reporting moderate to severe pain were randomized to receive a single 15-minute infusion of IV-APAP 1 g or ProAPAP 2 g (bioeyuivalent doses). Tolerability was monitored using local and systemic adverse event (AE) reporting, clinical examination including vital sign measurement, and patients' ratings of acceptability of the infusion. Efficacy end points included pain intensity at 0, 1, 2, 4, and 6 hours; median time to rescue medication (defined as the time at which 50% of patients requested rescue medication); and percentage of patients requesting rescue medication. Patients' satisfaction with the study drugs was assessed using patient's global evaluation (PGE) and the percentage of patients willing to receive the treatment again.

Results:

Of the 163 women who were randomized, 161 received the studymedication. The IV-APAP group comprised 80 patients (mean [SD] age, 38.3 [12.8] years [range, 18.0-69.0 years]; mean [SD] weight, 61.1 [11.0] kg [range, 49.0-90.0 kg]), and the ProAPAP group comprised 81 patients (mean [SD] age, 33.9 [12.0] years [range, 18.0-67.0 years]; mean [SD] weight, 61.6 [10.2] kg [range, 42.0-95.5 kg]); the difference in mean age between the 2 groups was statistically significant (P < 0.05). The incidence of local treatment-emergent AEs (TEAEs) was significantly lower in the IV-APAP group compared with that in the ProAPAP group (7.5% vs 38.3%; P < 0.001). No between-group differences in the incidence of systemic TEAEs was found. All patients in the IV-APAP group found the infusion tolerable, compared with 95% of patients in the ProAPAP group. The median time to rescue medication was not evaluated because <50% of the patients in each group requested it. No significant differences in mean pain intensity score or percentage of patients requesting rescue medication were found between the 2 groups at any time point. The percentages of patients in the IV-APAP and ProAPAP groups who rated the study medication as good or excellent on the PGE (83.6% vs 75.6%; P < 0.05) and who were willing to receive the same treatment again (96.0% vs 81.0%; P = 0.005) were significantly higher with IV-APAP compared with ProAPAP

Conclusion:

In these patients with moderate to severe pain after minor gynecologic surgery, a single dose of IV-APAP was associated with better local tolerability, similar analgesic efficacy, and greater patient satisfaction compared with a single bioequivalent dose of ProAPAP.     

Effects of granisetron in the treatment of nausea and vomiting after laparoscopic cholecystectomy: a dose-ranging study

BACKGROUND: Patients undergoing general anesthesia for laparoscopic cholecystectomy are at high risk for postoperative emetic symptoms (nausea, vomiting, and retching). Antihistamines, butyrophenones, dopamine receptor antagonists, and selective serotonin receptor antagonists (SSRAs) have been investigated for the prevention and treatment of emetic symptoms. However, these drugs are associated with undesirable adverse effects (AEs), such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations, and extrapyramidal signs. Granisetron hydrochloride is a newer SSRA developed for the prevention and treatment of cytotoxic drug-induced emetic symptoms, but its effects in postoperative laparoscopic cholecystectomy have not been studied. OBJECTIVE: The aims of this study were to assess the efficacy and tolerability of 4 doses of granisetron, and to determine the minimum effective dose, for the control of established emetic symptoms in patients undergoing general anesthesia for laparoscopic cholecystectomy. METHODS: This prospective, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in the Departments of Anesthesiology and Surgery, Toride Kyodo General Hospital (Toride, Japan). Male and female patients aged 23 to 68 years with American Society of Anesthesiologists physical status I (no organic, physiologic, biochemical, or psychiatric disturbance) who were experiencing nausea lasting >10 minutes or retching or vomiting within 3 hours after recovery from general anesthesia for laparoscopic cholecystectomy were enrolled. Patients were randomized to receive a single IV dose of placebo or granisetron at 1 of 4 doses (10, 20, 40, or 80 microg/kg). Patients were monitored for 24 hours after study drug administration. RESULTS: One hundred patients (60 women, 40 men; mean [SD] age, 48 [10] years [range, 23-68 years]; mean [SD] height, 158 [7] cm [range, 145-177 cm]; mean [SD] body weight, 56 [8] kg [range, 43-75 kg]) were enrolled. No significant differences in baseline demographic or clinical characteristics were found between the study groups. The proportions of patients who were free of emetic symptoms were significantly higher with granisetron 20, 40, and 80 microg/kg than with placebo (P = 0.02, 0.007, and 0.007, respectively). The difference between the granisetron 10-microg/kg group and the placebo group was not significant. No clinically significant AEs were reported in any group. CONCLUSIONS: Granisetron 20 microg/kg was the minimum effective dose for the treatment of established postoperative emetic symptoms in patients undergoing laparoscopic cholecystectomy. Increasing the dose to 80 microg/kg provided no further benefit.     

Is surgical airway necessary for airway management in deep neck infections and Ludwig angina?

Background

Deep neck infections are potentially life-threatening conditions because of airway compromise. Management requires early recognition, antibiotics, surgical drainage, and effective airway control. The Surgical Education and Self-Assessment Program 12 states that awake tracheostomy is the treatment of choice for these patients.

Hypothesis

With advanced airway control techniques such as retrograde intubation, GlideScope, and fiberoptic intubation, surgical airway is not required.

Design

A retrospective analysis of all deep neck abscesses treated from December1999 to July 2006 was performed.

Methods

All patients who underwent urgent or emergent surgery for Ludwig angina and submental, submandibular, sublingual, and parapharyngeal abscesses (Current Procedural Terminology codes 41015, 41016, 41017, 42320, and 42725) were included in our review. Charts were studied for age, presence of true Ludwig angina, presence of airway compromise, airway management, morbidity/mortality, and the requirement for surgical airway.

Results

Of 29 patients, 6 (20%) had symptoms consistent with true Ludwig angina. Nineteen (65.5%) had evidence of airway compromise. Eight (42%) of these 19 patients required advanced airway control techniques. No patient required a surgical airway, and no mortality resulted from airway compromise. Advance airway control techniques were required more often in patients with airway compromise (P < .05).

Conclusion

Treatment of Ludwig angina and deep neck abscesses requires good clinical judgment. Patients with deep neck infections and symptoms of airway compromise may be safely managed with advanced airway control techniques.     

Effects of Motor Imagery on Hand Function During Immobilization After Flexor Tendon Repair

Stenekes MW, Geertzen JH, Nicolai J-P, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair.

Objective

To determine whether motor imagery during the immobilization period after flexor tendon injury results in a faster recovery of central mechanisms of hand function.

Design

Randomized controlled trial.

Setting

Tertiary referral hospital.

Participants

Patients (N=28) after surgical flexor tendon repair were assigned to either an intervention group or a control group.

Intervention

Kinesthetic motor imagery of finger flexion movements during the postoperative dynamic splinting period.

Main Outcome Measures

The central aspects of hand function were measured with a preparation time test of finger flexion in which subjects pressed buttons as fast as possible following a visual stimulus. Additionally, the following hand function modalities were recorded: Michigan Hand Questionnaire, visual analog scale for hand function, kinematic analysis of drawing, active total motion, and strength.

Results

After the immobilization period, the motor imagery group demonstrated significantly less increase of preparation time than the control group (P=.024). There was no significant influence of motor imagery on the other tested hand function (P>.05). All tests except kinematic analysis (P=.570) showed a significant improvement across time after the splinting period (P≤.001).

Conclusions

Motor imagery significantly improves central aspects of hand function, namely movement preparation time, while other modalities of hand function appear to be unaffected.     

Gram-negative intravascular catheter-related bacteremia in patients with spinal cord injury

Hussain R, Cevallos ME, Darouiche RO, Trautner BW. Gram-negative intravascular catheter-related bacteremia in patients with spinal cord injury.

Objective

To determine whether the prevalence of gram-negative catheter-related bloodstream infection (CRBSI) is higher in patients with spinal cord injury (SCI) than in patients without SCI.

Design

Retrospective chart review from August 1998 to August 2006.

Setting

A Veterans Affairs medical center, which serves as a tertiary care medical center to over 500 veterans with SCI and is the primary source of health care for veterans in southeast Texas.

Participants

All hospitalized patients who had an International Classification of Diseases, Ninth Revision, code for bacteremia associated with their hospital stay.

Interventions

Not applicable.

Main Outcome Measure

The proportion of CRBSI caused by gram-negative organisms in the SCI patients to the proportion of CRBSI caused by gram-negative organisms in the non-SCI patients.

Results

Eight (42%) of 19 episodes of CRBSI in the SCI were caused by a gram-negative organism as compared with 4 (11%) of 36 infections in the non-SCI group (P<.01). Factors associated with having a gram-negative organism rather than a gram-positive organism as the causative agent of CRBSI were SCI, femoral catheter site, prolonged hospitalization, decubitus ulcer, and urinary catheter.

Conclusions

In our medical center, patients with SCI who develop CRBSI are more likely to have an infection with a gram-negative organism than are patients without SCI. This knowledge may guide initial empirical therapy of suspected bloodstream infection.     

A prospective, randomized, trial of phenobarbital versus benzodiazepines for acute alcohol withdrawal

Objective

The aim of this study was to compare phenobarbital (PB) versus lorazepam (LZ) in the treatment of alcohol withdrawal in the emergency department (ED) and at 48 hours.

Methods

Prospectively, randomized, consenting patients were assessed using a modified Clinical Institute Withdrawal Assessment (CIWA) score and given intravenous PB (mean, 509 mg) or LZ (mean, 4.2 mg). At discharge, LZ patients received chlordiazepoxide (Librium), and PB patients received placebo.

Results

Of 44 patients, 25 received PB, and 19 LZ. Both PB and LZ reduced CIWA scores from baseline to discharge (15.0-5.4 and 16.8-4.2, P < .0001). There were no differences between PB and LZ in baseline CIWA scores (P = .3), discharge scores (P = .4), ED length of stay (267 versus 256 minutes, P = .8), admissions (12% versus 16%, P = .8), or 48-hour follow-up CIWA scores (5.8 versus 7.2, P = .6).

Conclusion

Phenobarbital and LZ were similarly effective in the treatment of mild/moderate alcohol withdrawal in the ED and at 48 hours.     

An evaluation of potential signals for ventricular arrhythmia and cardiac arrest with dolasetron, ondansetron, and granisetron in the fda combined spontaneous reporting system/adverse event reporting system

Background:

Of the US Food and Drug Administration (FDA)-approved5-hydroxytryptamine type 3 (5-HT₃)-receptor antagonists, dolasetron, ondan-setron, granisetron, and palonosetron, only dolasetron and palonosetron have a precaution in their FDA labeling concerning corrected QT interval (QTc) prolongation. At FDA approved doses, QTc prolongation has been observed in clinical trials with some 5-HT₃ receptor antagonists (however, palonosetron has been only recently approved, with few published clinical data available). However, due to patient exclusion criteria, such trials with 5-HT₃ receptor antagonists may have failed to examine the risk of these agents in “real world” patients with cancer.

Objective:

The aim of this analysis was to assess the potential risk for selected cardiac adverse events associated with dolasetron, ondansetron, and granisetron use.

Methods:

The FDA combined Spontaneous Reporting System/Adverse Event Reporting System database was analyzed. The process of analyzing such a database for early warnings of potential hazards is known as signal generation. The statistical technique proportional reporting ratio (PRR) was used to aid detection of a potential signal within the database. PRR is the observed proportion of a given adverse event for the drug of interest (the number of events of interest for the drug divided by the total number of reports for the drug) divided by the expected proportion. Through the third quarter of 2002, the database was searched using the preferred term electrocardiogram qt corrected interval prolonged.

Results:

One, 3, and 0 cases were reported for dolasetron, ondansetron, andgranisetron, respectively. The number of cases did not satisfy 1 of the 3 criteria we utilized to define a potential signal, the 3 criteria being: 3 or more reported cases of the adverse event, a PRR value of at least 2, and a χ² value of >4. As this term may be unlikely to be reported, the database was also searched using the term ventricular arrhythmias and cardiac arrest. The PRR, used as a parameter to detect a potential signal within the database, was 3.23, 1.31, and 1.13 for dolasetron, ondansetron, and granisetron, respectively. The number of observed ventricular arrhythmias and cardiac arrests was ∼3-fold higher with dolasetron compared with the expected value (calculated by dividing the individual agent's total number of events reported by the proportion of adverse events for all agents combined). The results for dolasetron fulfilled the criteria we used to define a potential signal.

Conclusions:

This analysis detected a potential signal for ventricular arrhythmiasand cardiac arrest with dolasetron, but not with ondansetron or granisetron. However, there are limitations of a PRR analysis, which include only measuring cases that have been reported, providing relative frequencies instead of actual rates, and not providing information on the severity of adverse events or causal relationships. In addition, our analysis does not include consideration of concomitant medications, and only 2 search terms were used. Errors in identifying potential signals may also include confounding factors, such as the underlying disease, potential confusion with reporting under trade and generic names, and potential multiple reporting of the same case.     

Ultrasound Characteristics of the Deep Abdominal Muscles During the Active Straight Leg Raise Test

Teyhen DS, Williamson JN, Carlson NH, Suttles ST, O'Laughlin SJ, Whittaker JL, Goffar SL, Childs JD. Ultrasound characteristics of the deep abdominal muscles during the active straight leg raise test.

Objective

To determine whether changes in the transversus abdominis (TrA) and internal oblique (IO) muscles, as seen on ultrasound imaging, during the active straight leg raise (ASLR) test differ between subjects with and without unilateral lumbopelvic pain.

Design

Cross-sectional, case-control study.

Setting

Clinical laboratory.

Participants

Subjects (n=15) with unilateral symptoms in the lumbopelvic region and age-matched and sex-matched control subjects (n=15).

Interventions

Bilateral measurements of the deep abdominal muscles (TrA and IO) were obtained simultaneously using ultrasound imaging to compare the percent change in muscle thickness from rest with (1) immediately on raising, (2) after a 10-second hold, and (3) within 5 seconds after returning the lower extremity to the plinth.

Main Outcome Measure

Percent change in muscle thickness of both muscles from rest to the other 3 time intervals during the ASLR test.

Results

The 3-way group × side measured × time and 2-way side measured × time interactions were not significant for either the TrA (P≥.34) or the IO (P≥.14) muscles. The 2-way interaction group × time was significant for both the TrA (P=.003) and the IO (P=.02) muscles. On lifting the lower extremity, the control group demonstrated a 23.7% and 11.2% increase in TrA and IO muscle thickness, respectively, while those with lumbopelvic pain demonstrated a 6.4% and 5.7% increase in TrA and IO muscle thickness, respectively.

Conclusions

Although subjects with unilateral lumbopelvic pain demonstrated a smaller increase in muscle thickness, during the ASLR test there appears to be a symmetrical response in both of the deep abdominal muscles regardless of which lower extremity is lifted during the ASLR test or the unilateral nature of the symptoms. This study attests to the potential construct validity of using the ASLR test to assess different motor control strategies of the TrA and IO muscles in subjects with unilateral lumbopelvic pain.