Effects of intravenous diclofenac on postoperative sore throat in patients undergoing laparoscopic surgery at Aga Khan University Hospital,Nairobi: A prospective,randomized, double blind controlled trial

Background

postoperative sore throat is the commonest complication after endotracheal intubation. The efficacy of intravenous non-steroidal anti-inflammatory drugs in alleviating postoperative sore throat has not been investigated.

Objective

To evaluate the effect of intravenous diclofenac sodium on the occurrence and severity of postoperative sore throat.

Methods

42 in-patients scheduled for laparoscopic surgery were randomized into two equal groups to receive either a single dose of 75mg intravenous diclofenac sodium in addition to standard treatment taken at our hospital for the prevention of postoperative sore throat or to receive standard treatment only. All patients were interviewed postoperatively at 2, 6 and 18 hours. Data of the baseline characteristics, the incidence and severity of sore throat were collected. If sore throat was present, a Visual Analogue Score was used to assess its severity.

Results

the baseline characteristics of the participants were similar. The majority of the patients undergoing laparoscopic surgery were women. There was no statistically significant difference in the occurrence or severity of postoperative sore throat between the diclofenac and standard treatment groups at 2, 6 and 18 hours postoperatively.

Conclusion

Intravenous diclofenac sodium does not reduce the occurrence or severity of postoperative sore throat.     

Incidence and clinical variables associated with streptococcal throat infections: a prospective diagnostic cohort study

Background

Management of pharyngitis is commonly based on features which are thought to be associated with Lancefield group A beta-haemolytic streptococci (GABHS) but it is debatable which features best predict GABHS. Non-group A strains share major virulence factors with group A, but it is unclear how commonly they present and whether their presentation differs.

Aim

To assess the incidence and clinical variables associated with streptococcal infections.

Design and setting

Prospective diagnostic cohort study in UK primary care.

Method

The presence of pathogenic streptococci from throat swabs was assessed among patients aged ≥5 years presenting with acute sore throat.

Results

Pathogenic streptococci were found in 204/597 patients (34%, 95% CI = 31 to 38%): 33% (68/204) were non-group A streptococci, mostly C (n = 29), G (n = 18) and B (n = 17); rarely D (n = 3) and Streptococcus pneumoniae (n = 1). Patients presented with similar features whether the streptococci were group A or non-group A. The features best predicting A, C or G beta-haemolytic streptococci were patient’s assessment of severity (odds ratio [OR] for a bad sore throat 3.31, 95% CI = 1.24 to 8.83); doctors’ assessment of severity (severely inflamed tonsils OR 2.28, 95% CI = 1.39 to 3.74); absence of a bad cough (OR 2.73, 95% CI = 1.56 to 4.76), absence of a coryza (OR 1.54, 95% CI = 0.99 to 2.41); and moderately bad or worse muscle aches (OR 2.20, 95% CI = 1.41 to 3.42).

Conclusion

Non-group A strains commonly cause streptococcal sore throats, and present with similar symptomatic clinical features to group A streptococci. The best features to predict streptococcal sore throat presenting in primary care deserve revisiting.     

Leg Immersion in Warm Water,Stretch-Shortening Exercise,and Exercise-Induced Muscle Damage

Context:

Whether muscle warming protects against exercise-induced muscle damage is unknown.

Objective:

To determine the effect of leg immersion in warm water before stretch-shortening exercise on the time course of indirect markers of exercise-induced muscle damage.

Design:

Crossover trial.

Setting:

Human kinetics laboratory.

Patients or Other Participants:

Eleven healthy, untrained men (age  =  21.5 ± 1.7 years).

Intervention(s):

Participants'' legs were immersed in a water bath at 44 ± 1°C for 45 minutes.

Main Outcome Measure(s):

Creatine kinase changes in the blood, muscle soreness, prolonged (within 72 hours) impairment in maximal voluntary contraction force and height of drop jump, and electrically evoked muscle force at low and high stimulation frequencies at short and long muscle lengths.

Results:

Leg immersion in warm water before stretch-shortening exercise reduced most of the indirect markers of exercise-induced muscle damage, including creatine kinase activity in the blood, muscle soreness, maximal voluntary contraction force, and jump height. The values for maximal voluntary contraction force and jump height, however, were higher during prewarming than for the control condition at 48 hours after stretch-shortening exercise, but this difference was only minor at other time points. Muscle prewarming did not bring about any changes in the dynamics of low-frequency fatigue, registered at either short or long muscle length, within 72 hours of stretch-shortening exercise.

Conclusions:

Leg immersion in warm water before stretch-shortening exercise reduced most of the indirect markers of exercise-induced muscle damage. However, the clinical application of muscle prewarming may be limited, because decreasing muscle damage did not necessarily lead to improved voluntary performance.     

Addition of Montelukast to Low-Dose Inhaled Corticosteroid Leads to Fewer Exacerbations in Older Patients Than Medium-Dose Inhaled Corticosteroid Monotherapy

Purpose

There have been few reports regarding the efficacy of antiasthmatics in older patients. To compare the efficacy of the addition of montelukast to low-dose inhaled budesonide (MON-400BUD) versus increasing the dose of inhaled steroid (800BUD) on asthma control in older asthmatics.

Methods

A randomized, open-label, parallel-designed trial was conducted for 12 weeks. The primary endpoint was the rate of patients who reached "well-controlled asthma status" after the 12-week treatment period. Additionally, asthma exacerbations, sputum inflammatory cells, asthma control test (ACT) and physical functioning scale (PFS), and adverse reactions were monitored.

Results

Twenty-four (36.9%) and 22 (34.9%) subjects in the MON-400BUD (n=65) and 800BUD (n=63) groups had well-controlled asthma at the end of the study, respectively. The numbers of asthma exacerbations requiring oral corticosteroid treatment (20 vs 9, respectively, P=0.036) and the development of sore throat (22 vs 11, respectively, P=0.045) were significantly higher in the 800BUD group than in the MON-400BUD group. Body mass index and changes in ACT, FEV1%, 6-min walk distance and PFS from baseline were all significant determinants for distinguishing subjects with well-controlled and partly controlled asthma from those with uncontrolled asthma (P<0.05) at the end of the study.

Conclusions

The efficacy of 12-week treatment with MON-400BUD in older asthmatics was comparable to that of 800BUD on asthma control but associated with reduced frequency of asthma exacerbations requiring oral steroids and sore throat events. Changes in ACT and PFS can be useful predictors of asthma control status in older patients.     

Whole-body vibration and the prevention and treatment of delayed-onset muscle soreness

Context:

Numerous recovery strategies have been used in an attempt to minimize the symptoms of delayed-onset muscle soreness (DOMS). Whole-body vibration (WBV) has been suggested as a viable warm-up for athletes. However, scientific evidence to support the protective effects of WBV training (WBVT) on muscle damage is lacking.

Objective:

To investigate the acute effect of WBVT applied before eccentric exercise in the prevention of DOMS.

Design:

Randomized controlled trial.

Setting:

University laboratory.

Patients or Other Participants:

A total of 32 healthy, untrained volunteers were randomly assigned to either the WBVT (n  =  15) or control (n  =  17) group.

Intervention(s):

Volunteers performed 6 sets of 10 maximal isokinetic (60°/s) eccentric contractions of the dominant-limb knee extensors on a dynamometer. In the WBVT group, the training was applied using a vibratory platform (35 Hz, 5 mm peak to peak) with 100° of knee flexion for 60 seconds before eccentric exercise. No vibration was applied in the control group.

Main Outcome Measure(s):

Muscle soreness, thigh circumference, and pressure pain threshold were recorded at baseline and at 1, 2, 3, 4, 7, and 14 days postexercise. Maximal voluntary isometric and isokinetic knee extensor strength were assessed at baseline, immediately after exercise, and at 1, 2, 7, and 14 days postexercise. Serum creatine kinase was measured at baseline and at 1, 2, and 7 days postexercise.

Results:

The WBVT group showed a reduction in DOMS symptoms in the form of less maximal isometric and isokinetic voluntary strength loss, lower creatine kinase levels, and less pressure pain threshold and muscle soreness (P < .05) compared with the control group. However, no effect on thigh circumference was evident (P < .05).

Conclusions:

Administered before eccentric exercise, WBVT may reduce DOMS via muscle function improvement. Further investigation should be undertaken to ascertain the effectiveness of WBVT in attenuating DOMS in athletes.     

Effects and Side-Effects of Surgery for Snoring and Obstructive Sleep Apnea – A Systematic Review

Study Objectives:

Many patients undergo surgery for snoring and sleep apnea, although the efficacy and safety of such procedures have not been clearly established. Our aim was systematically to review studies of the efficacy and adverse effects of surgery for snoring and obstructive sleep apnea.

Design:

Systematic review.

Measurements:

PubMed and Cochrane databases were searched in September 2007. Randomized controlled trials of surgery vs. sham surgery or conservative treatment in adults, with daytime sleepiness, quality of life, apnea-hypopnea index, and snoring as outcomes were included. Observational studies were also reviewed to assess adverse effects. Evidence of effect required at least two studies of medium and high quality reporting the same result.

Results:

Four studies of benefits and 45 studies of adverse effects were included. There was no significant effect on daytime sleepiness and quality of life after laser-assisted uvulopalatoplasty and radiofrequency ablation. The apnea-hypopnea index and snoring was reduced in one trial after laser-assisted uvulopalatoplasty but not in another trial. Subjective snoring was reduced in one trial after radiofrequency ablation. No trial investigating the effect of any other surgical modality met the inclusion criteria. Persistent side-effects occurred after uvulopalatopharyngoplasty and uvulopalatoplasty in about half the patients and difficulty in swallowing, globus sensation and voice changes were especially common.

Conclusions:

Only a small number of randomized controlled trials with a limited number of patients assessing some surgical modalities for snoring or sleep apnea are available. These studies do not provide any evidence of effect from laser-assisted uvulopalatoplasty or radiofrequency ablation on daytime sleepiness, apnea reduction, quality of life or snoring. We call for research of randomized, controlled trials of surgery other than uvulopalatopharyngoplasty and uvulopalatoplasty, as they are related to a high risk of long-term side-effects, especially difficulty swallowing.

Citation:

Franklin KA; Anttila H; Axelsson S; Gislason T; Maasilta P; Myhre KI; Rehnqvist N. Effects and side-effects of surgery for snoring and obstructive sleep apnea – a systematic review. SLEEP 2009;32(1):27–36.     

Efficacy and Safety of 6-Month Nightly Ramelteon Administration in Adults with Chronic Primary Insomnia

Study Objectives:

Long-duration ( ≥ 6 months) polysomnographic studies of insomnia medications are lacking. This study evaluated the long-term efficacy of ramelteon, a selective MT₁/MT₂ melatonin-receptor agonist used for insomnia treatment.

Design:

Six-month, randomized, double-blind, placebo-controlled study.

Setting:

Forty-six investigative sites in the United States, Europe, Russia, and Australia.

Participants:

Four hundred fifty-one adults (age ≥ 18 years) with chronic primary insomnia.

Interventions:

Ramelteon, 8 mg, or placebo 30 minutes before bedtime nightly for 6 months.

Measurements:

Sleep was evaluated by polysomnography and morning questionnaires on the first 2 nights of Week 1; the last 2 nights of Months 1, 3, 5, and 6; and Nights 1 and 2 of the placebo run-out. Next-morning residual effects as well as adverse effects and vital signs were recorded at each visit. Rebound insomnia and withdrawal effects were evaluated during placebo run-out.

Results:

Over the 6 months of treatment, ramelteon consistently reduced latency to persistent sleep compared with baseline and with placebo; significant decreases were observed at Week 1 and Months 1, 3, 5, and 6 (P < 0.05). Ramelteon significantly reduced subjective sleep latency relative to placebo at Week 1, Month 1, and Month 5 (P < 0.05), with reductions nearing statistical significance at Months 3 and 6 (P ≤ 0.08). No significant next-morning residual effects were detected during ramelteon treatment. No withdrawal symptoms or rebound insomnia were detected after ramelteon discontinuation. Most adverse events were mild or moderate in severity.

Conclusions:

In adults with chronic insomnia, long-term ramelteon treatment consistently reduced sleep onset, with no next-morning residual effects or rebound insomnia or withdrawal symptoms upon discontinuation.

Citation:

Mayer G; Wang-Weigand S; Roth-Schechter B; Lehmann R; Staner C; Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. SLEEP 2009;32(3):351–360.     

GPs and involuntary admission: a qualitative study

Background

In many countries, medical authorities are responsible for involuntary admissions of mentally ill patients. Nonetheless, very little is known about GPs'' experiences with involuntary admission.

Aim

The aim of the present study was to explore GP''s experiences from participating in involuntary admissions.

Setting

General practice, Aarhus, Denmark.

Method

One focus group interview and six individual interviews were conducted with 13 Danish GPs, who had recently sectioned one of their own patients.

Results

GPs experienced stress and found the admission procedure time consuming. They felt that sectioning patients was unpleasant, and felt nervous, but experienced relief and professional satisfaction if things went well. The GPs experienced the doctor–patient relationship to be at risk, but also reported that it could be improved. GPs felt that they were not taken seriously by the psychiatric system.

Conclusion

The unpleasant experiences and induced feelings resulting from involuntary admissions reflect an undesirable and stressful working environment.     

Sustaining Executive Functions During Sleep Deprivation: A Comparison of Caffeine,Dextroamphetamine, and Modafinil

Objectives:

Stimulant medications appear effective at restoring simple alertness and psychomotor vigilance in sleep deprived individuals, but it is not clear whether these medications are effective at restoring higher order complex cognitive capacities such as planning, sequencing, and decision making.

Design:

After 44 hours awake, participants received a double-blind dose of one of 3 stimulant medications or placebo. After 45–50 hours awake, participants were tested on computerized versions of the 5-Ring Tower of Hanoi (TOH), the Tower of London (TOL), and the Wisconsin Card Sorting Test (WCST).

Setting:

In-residence sleep-laboratory facility at the Walter Reed Army Institute of Research.

Participants:

Fifty-four healthy adults (29 men, 25 women), ranging in age from 18 to 36 years.

Interventions:

Participants were randomly assigned to 1 of 3 stimulant medication groups, including caffeine, 600 mg (n = 12), modafinil, 400 mg (n = 12), dextroamphetamine, 20 mg (n = 16), or placebo (n = 14).

Measurements and Results:

At the doses tested, modafinil and dextroamphetamine groups completed the TOL task in significantly fewer moves than the placebo group, and the modafinil group demonstrated greater deliberation before making moves. In contrast, subjects receiving caffeine completed the TOH in fewer moves than all 3 of the other groups, although speed of completion was not influenced by the stimulants. Finally, the modafinil group outperformed all other groups on indices of perseverative responding and perseverative errors from the WCST.

Conclusions:

Although comparisons across tasks cannot be made due to the different times of administration, within-task comparisons suggest that, at the doses tested here, each stimulant may produce differential advantages depending on the cognitive demands of the task.

Citation:

Killgore WDS; Kahn-Greene ET; Grugle NL; Killgore DB; Balkin TJ. Sustaining Executive Functions During Sleep Deprivation: A Comparison of Caffeine, Dextroamphetamine, and Modafinil. SLEEP 2009;32(2):205–216.     

Placebo interventions in practice: a questionnaire survey on the attitudes of patients and physicians

Background

Few studies have investigated whether patients and physicians differ in their attitudes regarding placebo interventions in medical practice.

Aim

To compare the proportions of patients and physicians who would accept therapies that do not work through specific pharmacological or physiological action but by enhancing self-healing capacities and by exploiting contextual factors.

Design of study

Survey of a random sample of GPs and patients consecutively attending in primary care practices.

Setting

Four hundred and seventy-seven patients and 300 GPs from primary care practices of the Canton Zurich of Switzerland were approached.

Method

Two questionnaires on responders'' attitudes regarding non-specific therapies.

Results

The response rates were 87% for patients and 79% for GPs. Eighty-seven per cent of patients and 97% of GPs thought that physical complaints can get better by believing in the effectiveness of the therapy. Overall there was more support for placebo interventions among patients than among GPs, yet 90% of the physicians admitted to actively proposing treatments intended to take advantage of non-specific effects. Seventy per cent of the patients wanted to be explicitly informed when receiving a non-specific intervention, whereas physicians thought this was the case for only 33% of their patients. Fifty-four per cent of patients would be disappointed when learning they had unknowingly been treated with pure placebo (‘sugar pill’), while only 44% would feel that way after treatment with impure placebo (for example, herbal medicine).

Conclusion

GPs rather underestimate the openness of their patients to non-specific therapies. However, patients want to be appropriately informed. Developing specific professional standards could help physicians to harness the ‘power of the placebo’, while remaining authentic and credible.     

Long Working Hours and Sleep Disturbances: The Whitehall II Prospective Cohort Study

Study Objective:

To examine whether exposure to long working hours predicts various forms of sleep disturbance; short sleep, difficulty falling asleep, frequent waking, early waking and waking without feeling refreshed.

Design:

Prospective study with 2 measurements of working hours (phase 3, 1991–1994 and phase 5, 1997–1999) and 2 measurements of subjective sleep disturbances (phase 5 and phase 7, 2002–2004).

Setting:

The Whitehall II study of British civil servants.

Participants:

Full time workers free of sleep disturbances at phase 5 and employed at phases 5 and 7 (n = 937–1594) or at phases 3, 5, and 7 (n = 886–1510).

Measurements and Results:

Working more than 55 hours a week, compared with working 35–40 hours a week, was related to incident sleep disturbances; demographics-adjusted odds ratio (95% CI) 1.98 (1.05, 3.76) for shortened sleeping hours, 3.68 (1.58, 8.58) for difficulty falling asleep; and 1.98 (1.04, 3.77) for waking without feeling refreshed. Repeat exposure to long working hours was associated with odds ratio 3.24 (1.45, 7.27) for shortened sleep, 6.66 (2.64, 16.83) for difficulty falling asleep, and 2.23 (1.16, 4.31) for early morning awakenings. Some associations were attenuated after adjustment for other risk factors. To a great extent, similar results were obtained using working hours as a continuous variable. Imputation of missing values supported the findings on shortened sleep and difficulty in falling asleep.

Conclusion:

Working long hours appears to be a risk factor for the development of shortened sleeping hours and difficulty falling asleep.

Citation:

Virtanen M; Ferrie JE; Vahtera J; Elovainio M; Singh-Manoux A; Marmot MG; Kivimäki M. Long working hours and sleep disturbances: the whitehall II prospective cohort study. SLEEP 2009;32(6):737–745.     

The relationship between the oral and pharyngeal phases of swallowing

OBJECTIVE:

This study was designed to investigate a possible relationship between the duration of the oral and pharyngeal phases of swallowing.

INTRODUCTION:

The oral and pharyngeal phases of swallowing are independent from each other but may be related.

METHODS:

We used videofluoroscopy to evaluate 30 healthy volunteers between 29 and 77 years of age who swallowed 5- and 10-ml liquid and paste boluses in duplicate. The duration of the oral phase, pharyngeal transit, and pharyngeal clearance were measured.

RESULTS:

There were no differences in oral or pharyngeal transit times between the liquid and paste boluses or between the volumes of 5 and 10 ml (p>0.40). The pharyngeal clearance time for the paste bolus (0.48±0.27 s) was longer than for the liquid bolus (0.38±0.11 s, p = 0.03) with no difference between the volumes of 5 and 10 ml. There was no significant correlation between the oral transit time and the duration of pharyngeal transit for the liquid (5 ml, Spearman''s coefficient ρ: −0.14; 10 ml, ρ: 0.18) or the paste (5 ml, ρ: 0.08; 10 ml, ρ: 0.10). The correlation between the oral transit time and the pharyngeal clearance time was not significant for the liquid bolus (5 ml, ρ: 0.31; 10 ml, ρ: 0.18), but it was significant for both the 5 ml (ρ: 0.71) and 10 ml (ρ: 0.64) paste boluses.

DISCUSSION:

The relationship between the oral and pharyngeal phases of swallowing can be affected by bolus consistency.

CONCLUSION:

There is a correlation between the duration of oral transit and the duration of pharyngeal clearance during the swallowing of paste boluses.     

Electroacupuncture for Primary Insomnia: A Randomized Controlled Trial

Study Objectives:

To evaluate the short-term efficacy and safety of electroacupuncture for the treatment of primary insomnia.

Design:

Randomized, single-blind, placebo-controlled, parallel-group.

Setting:

A university-based sleep clinic.

Participants:

Community sample of 60 Chinese adult volunteers who report having insomnia 3 or more nights per week, whose symptoms meet the DSM-IV criteria for primary insomnia for at least 3 months, and who have an Insomnia Severity Index total score of at least 15. Participants were screened with polysomnography and the Structured Clinical Interview for the DSM-IV prior to randomization.

Intervention:

Electroacupuncture at Yintang (EX-HN3), Baihui (GV20), bilateral ear Shenmen, Sishencong (EX-HN1), and Anmian (EX) 3 times per week for 3 weeks or placebo acupuncture using Streitberger needles at the same points.

Measurements and Results:

Self-reported questionnaires, 1-week sleep diaries, and 3-day actigraphy were collected at baseline and 1 week after treatment. The Insomnia Severity Index was used as the primary outcome measure. Both groups showed significant improvement compared with the pretreatment baseline. One-way analysis of covariance adjusted for baseline scores showed that there were significantly greater improvements in sleep efficiency by sleep diary and actigraphy in the electroacupuncture group. However, no significant between-group differences were observed in the Insomnia Severity Index and other outcome measures. The proportions of subjects having less than 30 minutes of wake after sleep onset and a sleep efficiency of at least 85% at the posttreatment visit were significantly higher in the electroacupuncture group. All adverse events were mild in severity.

Conclusion:

We found a slight advantage of electroacupuncture over placebo acupuncture in the short-term treatment of primary insomnia. Because of some limitations of the current study, further studies are necessary to verify the effectiveness of acupuncture for insomnia.

Citation:

Yeung WF; Chung KF; Zhang SP; Yap TG; Law ACK. Electroacupuncture for primary insomnia: a randomized controlled trial. SLEEP 2009;32(8):1039-1047.     

Effect of sex education programme on at-risk sexual behaviour of school-going adolescents in Ilorin, Nigeria

Background

Adolescents display sexual behaviours and developmental characteristics that place them at risk for Sexually Transmitted Diseases (STDs). Because young people experiment sexually and because of the consequences of indiscriminate sexual activities on the youth, there is the need to mount sex education programmes that are geared towards enlightenment and appropriate education about sex and sexuality.

Objective

To determine whether Sex Education Intervention Programme would reduce at-risk sexual behaviours of school-going adolescents.

Design

Pre-test, post-test control group quasi-experimental design

Setting

A randomly selected co-educational school in Ilorin Metropolis, Nigeria

Participants

24 school-going adolescents aged 13–19 years

Intervention

Sex Education Programme (treatment group) versus Control programme (placebo)

Main Outcome Measures

Self-reported exposure to sexually transmitted diseases, multiple sex partners, anal sex, oral sex, non use of condom.

Result

When the treatment (intervention) group was compared with the control group in an intention to treat analysis, there were significant differences in at-risk sexual behaviours of the two groups. Those in the intervention group reported less at-risk sexual behaviours than their counterparts in the control group. The treatment group evaluated the intervention programme positively and their knowledge of sexual health improved. Lack of behavioural effect on the control group could be linked to differential quality of delivery of intervention.

Conclusion

Compared with the control group, this specially designed intervention sex education programme reduced at-risk sexual behaviour in adolescents. Based on this finding, it was recommended that sex education be introduced into the curriculum of secondary school education in Nigeria.     

Unilateral Hypoglossal Nerve Injury in a Collegiate Wrestler: A Case Report

Objective:

To introduce the case of a collegiate wrestler who suffered a traumatic unilateral hypoglossal nerve injury. This case presents the opportunity to discuss the diagnosis and treatment of a 20-year-old man with an injury to his right hypoglossal nerve.

Background:

Injuries to the hypoglossal nerve (cranial nerve XII) are rare. Most reported cases are the result of malignancy, with traumatic causes less common. In this case, a collegiate wrestler struck his head on the wrestling mat during practice. No loss of consciousness occurred. The wrestler initially demonstrated signs and symptoms of a mild concussion, with dizziness and a headache. These concussion symptoms cleared quickly, but the athlete complained of difficulty swallowing (dysphagia) and demonstrated slurred speech (dysarthria). Also, his tongue deviated toward the right. No other neurologic deficits were observed.

Differential Diagnosis:

Occipital-cervical junction fracture, syringomyelia, malignancy, iatrogenic causes, cranial nerve injury.

Treatment:

After initial injury recognition, the athletic trainer placed the patient in a cervical collar and transported him to the emergency department. The patient received prednisone, and the emergency medicine physician ordered cervical spine plain radiographs, brain computed tomography, and brain and internal auditory canal magnetic resonance imaging. The physician consulted a neurologist, who managed the patient conservatively, with rest and no contact activity. The neurologist allowed the patient to participate in wrestling 7 months after injury.

Uniqueness:

To our knowledge, no other reports of unilateral hypoglossal nerve injury from relatively low-energy trauma (including athletics) exist.

Conclusions:

Hypoglossal nerve injury should be considered in individuals with head injury who experience dysphagia and dysarthria. Athletes with head injuries require cranial nerve assessments.     

A Randomized,Double-Blind,Placebo-Controlled,Crossover Study of XP13512/GSK1838262 in the Treatment of Patients With Primary Restless Legs Syndrome

Study Objective:

To evaluate the efficacy and tolerability of XP13512/GSK1838262, an investigational nondopaminergic agent for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

Design:

Randomized, double-blind, placebo-controlled, crossover trial.

Setting:

Nine US clinical sites.

Patients:

Thirty-eight treatment-naïve subjects with RLS (mean ± SD age 50.1 ± 13.2 years).

Interventions:

XP13512 1800 mg/day followed by placebo or placebo followed by XP13512 1800 mg/day for 14 days, with a 7-day washout between treatment periods.

Measurements and Results:

The primary endpoint was mean change from baseline International RLS Study Group rating scale (IRLS) total score on Day 14, analyzed using analysis of variance with sequence, period, and treatment as fixed effects and subjects within sequence as a random effect. XP13512 significantly reduced IRLS total score on Day 14 compared with placebo (mean ± SD: XP13512 −12.1 ± 6.5, placebo −1.9 ± 6.3; P < 0.0001). Polysomnographic data showed that XP13512 significantly improved sleep architecture on Day 14 compared with placebo (mean ± SD change from baseline sleep time [minutes]: stage 1: XP13512 −9.8 ± 23.9, placebo 0.4 ± 23.2; adjusted P < 0.0054, nominal P < 0.0001; stage 3/4 (slow-wave sleep): XP13512 22.8 ± 40.8, placebo 1.4 ± 34.3; adjusted P = 0.0092, nominal P = 0.0002). The most frequently reported adverse events were somnolence (XP13512 30.6%, placebo 2.8%) and dizziness (XP13512 27.8%, placebo 5.6%).

Conclusions:

XP13512 1800 mg/day significantly reduced RLS symptoms, improved sleep, and was generally well tolerated in subjects with moderate-to-severe primary RLS across 14 days of treatment.

Citation:

Kushida CA; Walters AS; Becker P; Thein SG; Perkins AT; Roth T; Canafax D; Barrett RW. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. SLEEP 2009;32(2):159-168.     

Effect of vitamin A adjunct therapy for cerebral malaria in children admitted to Mulago hospital: a randomized controlled trial

Background

Malaria is a leading cause of mortality in Uganda accounting for 25% of deaths among children. Hitherto no adjunct therapy has been identified to improve outcome of cerebral malaria. Retinol suppresses growth of P.falciparum, scavenges free radicals, and exhibits synergistic action with quinine in parasite clearance.

Objective

To determine the effect of vitamin A supplementation on treatment outcome of cerebral malaria

Methods

In this randomised double-blind placebo controlled clinical trial we studied 142 children aged 6–59 months admitted with cerebral malaria in Mulago Hospital, Kampala. Children were randomised to either vitamin A or placebo and followed for 7 days. The main outcome measures were coma recovery time, time for convulsions to stop, and parasite and fever clearance. Secondary outcomes were overall mortality and time taken to start oral feeds.

Results

There was no difference in the coma recovery time (p=0.44), resolution of convulsions (p=0.37), fever clearance (p=0.92), parasite clearance (p=0.12), and starting oral feeds between the two treatment groups. Mortality was higher (16.2%) in the placebo than in the vitamin A group (8.1%): RR 1.4; 95% CI 1.0–2.1.

Conclusions

Vitamin A as adjunct therapy did not significantly reduce coma duration but there were fewer deaths in the vitamin A arm.     

Clinical dysphagia risk predictors after prolonged orotracheal intubation

OBJECTIVES:

To elucidate independent risk factors for dysphagia after prolonged orotracheal intubation.

METHODS:

The participants were 148 consecutive patients who underwent clinical bedside swallowing assessments from September 2009 to September 2011. All patients had received prolonged orotracheal intubations and were admitted to one of several intensive care units of a large Brazilian school hospital. The correlations between the conducted water swallow test results and dysphagia risk levels were analyzed for statistical significance.

RESULTS:

Of the 148 patients included in the study, 91 were male and 57 were female (mean age, 53.64 years). The univariate analysis results indicated that specific variables, including extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking, and other signs, were possible significant high-risk indicators of dysphagia onset. The multivariate analysis results indicated that cervical auscultation and coughing were independent predictive variables for high dysphagia risk.

CONCLUSIONS:

Patients displaying extraoral loss, multiple swallows, cervical auscultation, vocal quality, cough, choking and other signs should benefit from early swallowing evaluations. Additionally, early post-extubation dysfunction recognition is paramount in reducing the morbidity rate in this high-risk population.