Effectiveness of naproxen in laparoscopic sterilization: a double blind randomized placebo controlled study

Effectiveness of naproxen suppositories on ambulation was studied following laparoscopic sterilization. In a double-blinded randomized placebo study, 20 patients received 500 mg naproxen suppositories and 20 patients placebo suppositories. Postoperatively 10 naproxen patients and 11 placebo patients reported high pain scores, indicating severe pain and requiring opiates. Times to reach street fitness were equally prolonged in both groups. Most patients in both groups required 3 days to resume normal duties and post-discharge weakness was a common complaint. Our conclusion was that premedication with naproxen 500 mg suppositories in day-case laparoscopic sterilization therapeutically behaves like other commonly used non-steroidal anti-inflammatory drugs (NSAIDs) and does not substantially contribute to ambulation.     

Long term effects of azithromycin in patients with cystic fibrosis: A double blind, placebo controlled trial

BACKGROUND: Macrolides display immunomodulatory effects that may be beneficial in chronic inflammatory pulmonary diseases. The aim of the study was to document whether long term use of azithromycin may be associated with respiratory benefits in young patients with cystic fibrosis. METHODS: A multicentre, randomised, double blind, placebo controlled trial was conducted from October 2001 to June 2003. The criteria for enrollment were age older than 6 years and forced expiratory volume in 1 second (FEV1) of 40% or more. The active group received either 250 mg or 500 mg (body weight < or > or =40 kg) of oral azithromycin three times a week for 12 months. The primary end point was change in FEV1. RESULTS: Eighty two patients of mean (SD) age 11.0 (3.3) years and mean (SD) FEV1 85 (22)% predicted were randomised: 40 in the azithromycin group and 42 in the placebo group. Nineteen patients were infected with Pseudomonas aeruginosa. The relative change in FEV1 at month 12 did not differ significantly between the two groups. The number of pulmonary exacerbations (count ratio 0.50 (95% CI 0.32 to 0.79), p < 0.005), the time elapsed before the first pulmonary exacerbation (hazard ratio 0.37 (95% CI 0.22 to 0.63), p < 0.0001), and the number of additional courses of oral antibiotics were significantly reduced in the azithromycin group regardless of the infectious status (count ratio 0.55 (95% CI 0.36 to 0.85), p < 0.01). No severe adverse events were reported. CONCLUSION: Long term use of low dose azithromycin in young patients with cystic fibrosis has a beneficial effect on lung disease expression, even before infection with Pseudomonas aeruginosa.     

A six week double blind, placebo controlled, crossover study of the effect of misoprostol in the treatment of aspirin sensitive asthma

BACKGROUND: Prostaglandins of the E series and misoprostol (a stable analogue of prostaglandin E(1)) prevent bronchoconstriction following aspirin ingestion or inhalation in subjects with aspirin sensitive asthma. A study was undertaken to investigate the influence of misoprostol on the course of aspirin induced asthma. METHODS: A double blind, crossover, randomised, placebo controlled study was performed in 17 patients with aspirin sensitive asthma (13 women) aged 26-68 years. All subjects had aspirin sensitivity confirmed by means of oral aspirin or inhaled lysine aspirin challenge. Misoprostol (Cytotec, Searle, 800 or 1600 microg daily according to individual tolerance) or placebo were administered over a period of six weeks. Morning and evening peak expiratory flow rate (PEFR), beta(2) agonist use, asthma and rhinitis severity scores, and defaecation score were measured daily. At the beginning and end of each treatment period spirometric tests were performed and blood was taken for eosinophil count. Eight subjects took misoprostol at a dose of 800 microg and nine subjects at a dose of 1600 microg daily. RESULTS: No differences were seen in asthma control between misoprostol and placebo except for the rhinorrhoea score which was lower on misoprostol during the period of the study. CONCLUSION: Misoprostol in a daily dose of 800 or 1600 microg does not significantly improve asthma control in subjects with aspirin sensitive asthma.     

A double blind placebo controlled study to determine the effects of intermittent cyclical etidronate on bone mineral density in patients on long term oral corticosteroid treatment

BACKGROUND—A double blind, placebo controlledstudy was undertaken to determine the effects of 104 weeks ofintermittent cyclical etidronate therapy on bone mineral density (BMD)in patients undergoing long term oral corticosteroid therapy.
METHODS—Forty nine patients of mean age 59 yearson long term (>6 months) corticosteroid treatment were randomised toreceive either 400 mg/day etidronate or placebo for 14 days followedin both groups by calcium (equivalent to 97 mg elemental Ca/day) with vitamin D (400 IU) for 76 days. The cycle was repeated a total of eighttimes over a period of two years. Dual energy x rayabsorptiometry (DEXA) measurements of the lumbar spine and hip BMD andbiochemical bone marker analyses were performed at baseline and everysix months.
RESULTS—Twenty six patients (10 men) receivedcyclical etidronate and 23 (nine men) received placebo. The mean (SD)dose of corticosteroid (prednisone or equivalent) at baseline in theetidronate group was 8 (4) mg/day and in the placebo group was 7 (4) mg/day. Most of the patients (43%) suffered from asthma. Fortyone patients completed the study (22 in the etidronate group and 19 inthe placebo group). All had a low BMD at entry and with treatment asignificant difference was observed between groups in the mean (SE)percentage change from baseline in lumbar spine BMD at week 104 of 4.5 (1.65)% (p = 0.007) with a 95% confidence interval (CI) of 1.12 to7.87%. No clinically or statistically significant treatmentdifferences were observed at the hip or with bone markers. Theincidence of adverse events was similar in the two groups.
CONCLUSIONS—The results show that intermittentcyclical etidronate therapy with calcium and vitamin D supplementationsignificantly increases lumbar spine BMD in patients with osteoporosisresulting from long term treatment with corticosteroids.

     

Nedocromil sodium in adults with asthma dependent on inhaled corticosteroids: a double blind, placebo controlled study.

Eighty nine adults with asthma who were receiving inhaled corticosteroid and bronchodilator treatment took part in a double blind, randomised, placebo controlled trial of nedocromil sodium, 4 mg four times daily by inhalation. During a run in period of two to four weeks corticosteroid treatment was reduced when possible to produce a comparable level of symptoms across the trial population. The test treatment was then taken for four weeks, with the severity of asthma recorded daily by patients and assessed at two weekly hospital visits. There was an improvement in symptoms in the patients taking nedocromil sodium by comparison with those having the placebo, the differences being significant for diary card PEF readings, asthma symptom scores, and bronchodilator usage at night. The mean difference between the two groups was 18 l/min for PEF, 0.42 for daytime asthma score, and 1.73 puffs in 24 hours for bronchodilator usage. These results suggest that asthmatic patients who require inhaled steroids show better control of their asthma with the addition of nedocromil sodium than of placebo over a four week period after reduction of the dosage of their inhaled steroids.     

Efficacy of inhaled salmeterol in the management of smokers with chronic obstructive pulmonary disease: a single centre randomised, double blind, placebo controlled, crossover study.

BACKGROUND--The acute response to bronchodilators in patients with chronic obstructive pulmonary disease (COPD) is modest; it has, however, been suggested that these patients may benefit from long term treatment. METHODS--To investigate the efficacy of salmeterol in smokers with moderate to severe COPD a double blind, randomised, crossover comparison was performed between salmeterol (50 micrograms twice daily) and placebo in 63 patients with stable COPD (mean age 65 years). Prior to inclusion, all patients had a forced expiratory volume in one second (FEV1) of < 60% of predicted and an improvement in FEV1 of < 15% following 400 micrograms inhaled salbutamol. Patients received four weeks of therapy with each of the treatment regimens. Assessment of efficacy was made with recording of morning and evening peak expiratory flow rates (PEF), respiratory symptoms, and use of rescue salbutamol. FEV1 was measured before and after nebulised salbutamol prior to randomisation and at the end of each treatment period. RESULTS--Morning PEF values were higher during the salmeterol than during the placebo period, although the mean treatment difference was small (12 l/min (95% confidence limits 6 to 17)). No difference in mean evening PEF values was found. Diurnal variation in PEF, assessed as the difference between the morning PEF and that of the previous evening, was more pronounced during the placebo than during the salmeterol period. The mean spirometric values (including reversibility in FEV1) obtained at the end of the two treatment periods were similar. Compared with placebo, treatment with salmeterol was associated with lower daytime and night time symptom scores and less use of rescue salbutamol both during the day and the night. The patients rated the treatment with salmeterol better than treatment with placebo. CONCLUSIONS--This study shows that, compared with placebo, treatment with salmeterol produces an improvement in respiratory symptoms and morning PEF values in patients with moderate to severe COPD. Treatment with long acting beta agonists may therefore result in an improvement in functional status, even in patients suffering from apparently nonreversible obstructive pulmonary disease.     

Ketamine for treatment of catheter related bladder discomfort: a prospective, randomized, placebo controlled and double blind study

Background. Intraoperative urinary catheterization might causepostoperative catheter related bladder discomfort (CRBD). Weevaluated the efficacy of ketamine as a treatment modality forCRBD. Methods. Fifty-four, ASA physical status I and II, male andfemale adult patients, having CRBD after elective percutaneousnephrolithotomy were randomized into two equal groups of 27each. In the postoperative period, patients who complained ofCRBD received medication depending upon group allocation. Group1 (Control) received placebo, Group II (Ketamine) received i.v.ketamine 250 µg kg^–1. After induction of anaesthesiapatients were catheterized with a 16 Fr Foley's catheter andthe balloon was inflated with 10 ml distilled water. Gradingof CRBD was done as none, mild, moderate and severe by a blindedobserver at 0, 1, 2 and 6 h after operation. Results. Ketamine reduced the incidence of CRBD (P<0.001)at 2 and 6 h along with reduction in severity (P<0.05) at1 h compared with control. Higher incidence of mild sedationwas observed in the ketamine group (P<0.05) which was notassociated with any untoward effects. Operative time and intraoperativefentanyl requirement were similar in both the groups. Conclusion. I.V. ketamine (250 µg kg^–1) is an effectivetreatment for reducing the incidence and severity of postoperativeCRBD.     

Continuous intravenous intradialysis versus intravenous postdialysis erythropoietin therapy in chronic haemodialysis patients: a randomized, controlled, crossover study

Background: Subcutaneous recombinant human erythropoietin seems to be more effective than intravenous administration. Local pain, however, may diminish patient compliance with the subcutaneous route. Recently continuous intravenous intradialysis administration of rHuEpo has been reported to be more efficacious in stimulating erythropoiesis than the usual postdialysis intravenous bolus. Methods: We conducted a randomized, controlled, crossover study on stable chronic haemodialysis patients to compare the efficacy of continuous intradialysis rHuEpo therapy with intravenous postdialysis administration. Twenty patients were selected and randomly assigned to receive rHuEpo either postdialysis (control phase) or by continuous intradialysis perfusion (slow Epo phase) for 12 weeks. After this period, patients were switched to the alternative method for 12 additional weeks. The erythropoietin dose remained unchanged during the study. Haematocrit was monitored weekly and iron metabolism, serum Epo, and vitamins were measured monthly. Urea kinetics and iPTH measurements were performed every 3 months. Results: Three patients were excluded because of unrelated problems. The final mean haematocrit was unchanged from previous basal values in both phases and no statistical differences were found for any parameter between the groups. No differences were found in iron metabolism nor in urea kinetic parameters. Conclusions: Continuous intravenous intradialysis administration of rHuEpo is no more effective than an intravenous postdialysis bolus as rHuEpo maintenance therapy in stable chronic haemodialysis patients.     

Randomised,placebo controlled,double blind study of alfuzosin SR in patients undergoing trial without catheter following acute urinary retention

INTRODUCTION: Acute urinary retention caused by bladder outlet obstruction resulting from prostatic enlargement is one of the commonest causes for acute admission to urology wards. More recently, there has been a trend to commence treatment with alpha-blockers after catheterisation followed by a trial without catheter (TWOC), in the hope that surgery may be avoided in a significant proportion of patients. There is no conclusive evidence of the efficacy of this treatment. We conducted a study to evaluate the efficacy of using the alpha-blocker alfuzosin SR in patients with acute urinary retention. PATIENTS AND METHODS: All patients presenting with acute urinary retention to our unit were included in the trial. Exclusion criteria included patients with known bladder or prostate malignancy, bladder calculi, urinary tract infections, urethral stricture or patients on alpha-blockers. A total of 81 patients consented and were randomised. Sixty-two patients completed the study. The retention volume was recorded. Trial medicine was recorded on a twice-daily dose and the first TWOC was carried out after a minimum of three doses or 36 hours after admission. TWOC was considered successful on voiding with a residual volume of <200 ml. Unsuccessful patients were recatheterised and discharged home on trial medication, and called for a second TWOC after 2 weeks. Successful patients were continued on alpha-blockers and failures were put on the operating list for TURP. Patients on active treatments were reviewed at 2 year. RESULTS: Of the 34 patients treated with alfuzosin SR, 17 (50%) resumed voiding and of the 28 patients from placebo group, 16 (57%) voided successfully. All 33 patients were continued open labelled on alfuzosin SR 5mg BD. Out of 33 patients, 13 (43%) had TURP within first year after TWOC and three died due to various medical causes. Out of remaining 17 patients, 15 attended for follow-up. The mean peak flow rate was 8.4 ml/s and the mean residual volume was 112 ml. Six patients (40%) required TURP for severe lower urinary tract symptoms (LUTS). So out of 28 patients followed at 2 year, 19 (68%) had TURP. CONCLUSIONS: These data do not support the routine use of alpha-blockers in patients with acute urinary retention. Also continuing use of alpha-blockers does not seem to prevent further requirements of TURP, although larger studies are needed to support this.     

A four arm,double blind,randomized and placebo controlled study of pregabalin in the management of post-burn pruritus

Post-burn itch is a distressing symptom in burns rehabilitation and its treatment often proves frustrating for the patient and the multidisciplinary burns team. Traditionally, the mainstay of antipruritic therapy for decades has been antihistamines and massage with emollients. With a better understanding of the neurophysiology of itch emerged a new dimension in the treatment of post-burn pruritus. Gabapentin, a centrally modulating anti-epileptic agent and α2δ ligand, proved in clinical trials to be immensely better in the treatment of post-burn pruritus. Pregabalin is a newer structural analog of gabapentin. It has a much better anxiolytic effect and pharmacokinetic profile as compared to gabapentin. The current study was initiated to specifically study the role of pregabalin in relieving post-burn itch as this has never been investigated before. This double blind, randomized and placebo controlled study had four arms and was carried out on 80 adult patients (20 each). The four arms were: pregabalin, cetirizine with pheniramine maleate, combination of pregabalin, cetirizine and pheniramine maleate, and placebo (vit. B comp.). Massage with coconut oil was integral to all groups. Drug dosage was determined by initial VAS (visual analog scale) scores. All groups matched in demographic data and initial VAS scores. VAS scores were evaluated over next 28 days (days 3, 7, 14, 21 and 28). In patients with mild itch (VAS scores 2–5) or moderate itch (VAS scores 6–8) near complete remission of itch was seen in combination group and pregabalin group where the response was comparable and close to 95%. This was significantly better response than antihistaminic combination or massage alone. However, massage alone was sufficient in decreasing mean scores in mild itch, in a large percentage of patients. Amongst the patients with severe itch (VAS scores 9–10), 3/6 and 6/7 patients dropped out of trial in the antihistaminic and placebo groups, respectively. Combination therapy and pregabalin alone had exactly similar decrease in itch scores by day 28 (78.9%). This far exceeded the response in the antihistaminic and placebo groups (23.9% and 9.2% respectively). We conclude that moderate to severe pruritus (VAS 6–10) should be treated with a systemic, centrally acting agent like pregabalin or gabapentin to eliminate itch or bring it down to tolerable limits. Patients with mild itch having VAS scores between 4 and 5 may be better served with addition of pregabalin even if massage and antihistaminics can control post-burn itch to a reasonable extent because of quicker, predictable and complete response, along with anxiolysis.     

Effect of pre-operative short course famotidine on tumor infiltrating lymphocytes in colorectal cancer: a double blind, placebo controlled, prospective randomized study

BACKGROUND: Pilot studies have shown that histamine H2 receptor antagonists augment the natural immunity against cancer in colorectal and gastric cancer by enhancing lymphocytic infiltration in the tumors. However, a study of adjuvant ranitidine failed to show a significant benefit in colorectal cancer, possibly because of the immunosuppression exerted by blood transfusion and post-operative infections. The pre-operative use of H2 receptor antagonists may therefore be of greater benefit. Except for a pilot study using cimetidine, there are no trials that have evaluated the effect of pre-operative H2 receptor antagonists on tumor infiltrating lymphocytes in colorectal cancer. OBJECTIVE: To evaluate the efficacy of famotidine in augmenting tumor infiltrating lymphocytes in colorectal cancer. STUDY DESIGN: Double blind, placebo controlled, prospective randomized study. METHODS: Twenty-three patients with resectable colorectal cancer were randomized to receive famotidine (n = 11) or placebo (n = 12). Famotidine was given for 1 week pre-operatively in a dose of 40 mg per day p.o. After resection, the specimens were analyzed histologically for lymphocytic infiltration by a pathologist blinded to the two groups. Lymphocytic infiltration more than 50 cells per high power field, involving more than 50% of the tumor-normal tissue interface was considered significant. RESULTS: The two groups were comparable for age, gender, pre-operative carcino embryonic antigen (CEA) levels and pathological stage. Significant lymphocytic infiltration was seen in 63.6% (7 of 11) patients in the study group compared to only 8.5% (1 of 12) patients in the placebo group (P = 0.005). Despite fewer recurrences and a longer survival in the study group, the difference was not significant. CONCLUSION: This study shows that pre-operative famotidine may significantly enhance lymphocytic infiltration in colorectal cancer and may have potential for use as an anticancer agent in colorectal cancer.     

Intranasal fentanyl is an equivalent analgesic to oral morphine in paediatric burns patients for dressing changes: a randomised double blind crossover study

INTRODUCTION: The ideal analgesic agent for burns wound dressings in paediatric patients would be one that is easy to administer, well tolerated, and produces rapid onset of analgesia with a short duration of action and minimal side-effects to allow rapid resumption of activities and oral intake. We compared our current treatment of oral morphine to intranasal fentanyl in an attempt to find an agent closer to the ideal. METHODS: A randomised double blind two-treatment crossover study comparing intranasal administration of fentanyl (INF) to orally administered morphine (OM). Children with burn injury aged up to 15 years and weighing 10-75 kg were included. Primary end-point was pain scores. Secondary end-points were time to resumption of age-appropriate activities, time to resumption of fluid intake, sedation and cooperation. Routine observations and vital signs were also recorded. RESULTS: Twenty-four patients were studied with a median age of 4.5 years (interquartile range 1.8-9.0 years) and a median weight of 18.4 kg (interquartile range 12.9-33.2kg). Mean pain difference scores (OM-INF) ranged from -0.500 (95% CI=-1.653 to 0.653) at baseline to -0.625 (05% CI=-1.863 to 0.613) for a retrospective rating of worst pain experienced during the dressing procedure. All measurements were within a pre-defined range of equivalent efficacy. The median time to resumption of fluid intake was 108 min (range 44-175 min) with OM and 140 min (range 60-210 min) with INF. These differences were not statistically significant. Fewer patients experienced mild side-effects with INF compared to OM (n=5 versus n=10). No patients experienced depressed respirations or oxygen saturations. SUMMARY: Intranasal fentanyl was shown to be equivalent to oral morphine in the provision of analgesia for burn wound dressing changes in this cohort of paediatric patients. It was concluded that intranasal fentanyl is a suitable analgesic agent for use in paediatric burns dressing changes either by itself or in combination with oral morphine as a top up titratable agent.     

Effects of ranitidine treatment on patients with asthma and a history of gastro-oesophageal reflux: a double blind crossover study.

Forty eight patients with moderate to severe asthma were enrolled in a double blind crossover study designed to evaluate the effects of ranitidine treatment, 150 mg twice daily for four weeks, on gastro-oesophageal reflux, asthma control, and bronchial reactivity. All 48 had a history of reflux symptoms and 27 had in addition reflux associated respiratory symptoms. Thirty two patients had objective evidence of acid reflux on 24 hour pH monitoring (pH of less than 4 for more than 1% of the 24 hours) and 27 patients had a positive result in the acid perfusion test. Reflux symptoms were significantly improved after ranitidine treatment. Ranitidine treatment was associated with modest improvements in nocturnal asthma and daily use of inhaled bronchodilator drugs but there was no significant change in bronchial reactivity, lung function, peak flow, or the number of eosinophils in the blood. Comparisons between the effect of ranitidine treatment on asthma control were performed between patients with and without a history of reflux associated respiratory symptoms, with and without a positive result in the acid perfusion test, and with and without objective evidence of gastro-oesophageal reflux. A history of reflux associated respiratory symptoms was the only factor that predicted an improvement in asthma control after ranitidine treatment. These results indicate that antireflux treatment will produce only small improvements in asthma control in asthmatic patients with a history of gastro-oesophageal reflux.     

Evaluation of intravenous hydrocortisone in reducing headache after spinal anesthesia: a double blind controlled clinical study [corrected

BACKGROUND: Headache after spinal anesthesia is a common complication is patients undergoing this procedure. In this study we evaluated the efficacy of intravenous hydrocortisone in the treatment of headache after spinal anesthesia in women who have undergone cesarean section. METHODS: Sixty patients with headache after spinal anesthesia were included. Patients randomly allocated into two groups, 30 patients received only conventional therapy (complete bed rest, hydration, acetaminophen and pethidine). Other 30 patients received conventional therapy plus intravenous hydrocortisone (200 mg first, then 100 mg TID for 48 hours). Mean (+/- SD) of headache intensity at 0, 6, 24, and 48 hours after beginning of treatment was measured using visual analog scale. RESULTS: There was no significant difference in headache intensity between two groups before beginning of treatment. After 6 hours, the mean of headache intensity in 30 patients treated conventionally was 6.63 (+/- 1.35) while it was 2.77 (+/- 1.07) in other patients received intravenous hydrocortisone too (p <0.001). After 24 hours, mean headache intensity was 3.87 (+/- 1.63) in conventionally treated group versus 0.73 (+/- 0.74) in hydrocortisone group (p <0.001). After 48 hours, mean headache intensity was 1.87 (+/- 0.93) in conventionally treated group versus 0.63 (+/- 0.61) in hydrocortisone group (p = 0.001). CONCLUSIONS: This study showed the therapeutic effects of intravenous hydrocortisone in reducing headache after spinal anesthesia in women who underwent cesarean section. Its mechanism of action is yet to be determined.     

Effect of an oral potassium channel activator, BRL 38227, on airway function and responsiveness in asthmatic patients: comparison with oral salbutamol.

BACKGROUND: Potassium (K+) channel activators, such as cromakalim, open ATP sensitive K+ channels and relax airway smooth muscle in vitro and inhibit induced bronchoconstriction in vivo in animals. The prolonged half life of cromakalim gives it potential as an oral bronchodilator. The effect of orally administered BRL 38227 (the active enantiomer of cromakalim), at doses of 0.125, 0.25, and 0.5 mg, on airway function and airway responsiveness to histamine and methacholine has been investigated in asthmatic patients. METHODS: Seventeen patients with asthma were studied in three separate randomised double blind, placebo controlled studies. In the first study eight patients with moderately severe asthma were given 0.125, 0.25, and 0.5 mg of BRL 38227 or placebo, and responses to histamine were assessed before and five hours after treatment. In the second study responses to methacholine were measured before and five hours after 0.125 and 0.5 mg of BRL 38227 or placebo were given to nine patients with mild asthma. In the third study the effect of 0.5 mg of BRL 38227 or placebo was assessed in eight patients with mild asthma. Responses to histamine were measured before treatment and two and five hours after treatment. To provide a positive control study eight subjects who had taken part in studies 1 and 3 were also given oral salbutamol (8 mg) in a placebo controlled, double blind study. Responses to histamine were assessed before and two hours after treatment. RESULTS: BRL 38227 did not cause significant bronchodilatation or changes in airway responsiveness in any of the studies. Headache was reported in 19 of 25 of patients receiving (in some cases twice) 0.5 mg of BRL 38227. By contrast, oral salbutamol gave significant protection against histamine challenge (geometric mean 2.23 doubling dilutions). CONCLUSIONS: After a single oral dose of BRL 38227 no beneficial effect on airway function was detected, despite a high incidence of side effects, which indicates that the orally administered K+ channel activator BRL 38227 may not be useful in the management of asthma.     

Single dose parecoxib significantly improves ventilatory function in early extubation coronary artery bypass surgery: a prospective randomized double blind placebo controlled trial

Background. Parecoxib, a cyclo oxygenase-2 inhibiting non-steroidalanti-inflammatory drug, has been widely used for postoperativeanalgesia. Our aim was to quantify the benefit of a single doseafter coronary artery bypass grafting. Methods. The investigation was carried out as a randomized doubleblind placebo controlled study. A single i.v. dose of parecoxib40 mg or placebo was given at closure of sternotomy. No opioidother than morphine was given in the first 24 postoperativehours. Pain was assessed using both a Visual Analogue Score(1–10), and the amount of morphine used via a morphinepatient controlled analgesia pump. Creatinine clearance wasmeasured before and after operation from 24 h urine collections.After a global announcement by Pfizer that paracoxib was ‘contraindicatedin patients with ischaemic heart disease’ further recruitmentwas suspended and the collected data from 40 patients were analysed. Results. Twenty-one patients received parecoxib and 19 receivedplacebo. Amongst those who received parecoxib, there was a highlysignificant sparing of rescue medication before tracheal extubation(P=0.004) compared with placebo, and an overall 35% morphinesparing effect during the first 6 h post extubation after correctionfor the variability in extubation time (P=0.037). Respiration,as measured by arterial carbon dioxide tension at the time ofextubation, was significantly better in the parecoxib group(P=0.045). Significantly more furosemide was given for postoperativeoliguria in those patients who received parecoxib (P=0.036).After correcting for differences in diuretic usage and fluidbalance, parecoxib was associated with a significant increasein plasma creatinine (P=0.041). Conclusion. A single dose of parecoxib has a significant opioidsparing effect in the first 6 h after coronary artery bypassgrafting which resulted in significantly improved ventilationwith mild elevation of plasma creatinine within normal limits.     

A placebo controlled double blind study using perioperative prazosin in the prevention of urinary retention following inguinal hernia repair

Acute urinary retention is a frequent complication following inguinal hernia repair. The smooth muscle of the bladder neck and the prostate have been demonstrated to be rich in alpha-1 adrenergic receptors. It has been postulated that the aetiology of acute urinary retention postoperatively is at least partially due to adrenergic stimulation, blocking these receptors may reduce the incidence of acute urinary retention. We have used prazosin in a double blind, placebo controlled study to establish its efficacy in the prevention of acute urinary retention in patients undergoing elective inguinal hernia repair. A total of 70 male patients were enrolled; 36 patients had been allocated active drug and 34 patients had been allocated placebo. Only two patients developed acute urinary retention. Both patients had been allocated prazosin and had received a general anaesthetic for their hernia surgery. In either arm of the study, a higher number of patients developing urinary retention would have been expected but this may be explained by the greater vigilance on urinary output by nursing staff aware that the trial was being conducted. On the basis of our findings, we do not recommend the routine use of perioperative prazosin with inguinal hernia repair. Further studies in high risk groups would be necessary to assess more fully the efficacy of prazosin in this situation.