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PubMed1989

Clinical benefits of early cold therapy in accident and emergency following ankle sprain.

One hundred and forty-three patients presenting with ankle sprains within 24 h of injury were entered into a double blind study. Treatment consisted of a standardized regime of high dose non-steroidal anti-inflammatory medication and an elastic support for all patients, who were then randomly allocated to two groups. One group received immediate cold therapy, the other received simulated therapy. Assessments made at 7 days showed a trend in favour of the group receiving cold therapy, although this did not reach significance. It is concluded that cold therapy together with compression may have a beneficial effect but that a single application in the accident and emergency department is not justified when a background therapy of non-steroidal anti-inflammatory medication is given.

Adolescent↗

PubMed1989

Laser vaporization versus laser excision conization in the treatment of cervical intraepithelial neoplasia.

One hundred patients with histologically confirmed cervical intraepithelial neoplasia suitable for ablative therapy were randomly allocated to treatment by either laser vaporization or laser excision conization under local anesthesia in the outpatient colposcopy clinic. The two methods were compared with respect to the immediate surgical complications, ease of performance, and long-term complications. They were comparable in most respects, and both were well accepted by the patients. Laser excision had the added advantage of providing further material for histologic examination to confirm the absence of invasion and the completeness of excision of the lesion.

Adolescent↗

PubMed1983

A multicentre general practice study comparing pivampicillin (Pondocillin) and amoxycillin (Amoxil) in respiratory tract infections.

Seven-day courses of either pivampicillin (Pondocillin) 500 mg twice daily or amoxycillin (Amoxil) 250 mg three times daily were compared in a multicentre general practice study in 463 patients with symptoms of upper or lower respiratory tract infections. Patients were stratified into four diagnostic groups: sinusitis, otitis media, throat infections, and acute bronchitis, and randomly allocated to treatment within these groups. There was an over-all response of 93% in the 227 patients receiving 12-hourly pivampicillin compared with 90% for the 236 patients receiving 8-hourly amoxycillin. Patients suffering from acute bronchitis responded significantly better to pivampicillin (Pondocillin) than to amoxycillin. Side-effects were reported by 15.6% of patients in the amoxycillin group and 14.0% in the pivampicillin group.

Acute Disease↗

PubMed2006

Comparison of remifentanil or fentanyl administration during isoflurane anesthesia for coronary artery bypass surgery.

BACKGROUND: The combination of inhalational agents with moderate doses of fentanyl is popular in cardiac anesthesia. Remifentanil is a new opioid metabolized by non-specific esterases. The aim of our study was to assess whether remifentanil may be superior to fentanyl during isoflurane anesthesia for coronary artery surgery. MATERIAL/METHODS: Forty patients aged 40-70 years with stable coronary artery disease were randomly allocated to two groups: remifentanil was used in 20 patients (group I) and fentanyl was used in 20 patients (group II). Induction of anesthesia was performed with remifentanil infusion (0.5 microg/kg/min) or a bolus dose of fentanyl (5 microg/kg) followed by a bolus of etomidate and pancuronium. Maintenance of anesthesia was provided by isoflurane and infusion of the study opioid, with the rate adjusted according to systolic blood pressure values. Hemodynamic parameters were registered before and after the induction of anesthesia, skin incision, sternotomy, aortic cannulation, termination of cardiopulmonary bypass, chest closure, and skin closure. RESULTS: Heart rate and mean arterial pressure values were significantly lower in the remifentanil group, while systemic vascular resistance was higher in the fentanyl group in the measurements taken before the initiation of cardiopulmonary bypass. No differences were found between groups in the values of mean pulmonary pressure, pulmonary artery wedge pressure and transpulmonary pressure gradient, central venous pressure, and cardiac index. CONCLUSIONS: Remifentanil is safe during inhalation anesthesia for coronary artery surgery and it appears to be more effective than fentanyl in blunting hemodynamic response before the initiation of cardiopulmonary bypass surgery.

Adult↗

PubMed1992

The use of temazepam elixir in surgical dental sedation: a comparison with intravenous midazolam.

Out-patients attending for removal of at least one lower third molar were randomly allocated to treatment with temazepam elixir (n = 7) or intravenous midazolam (n = 8), as well as local analgesia. Patients were tested prior to drug administration and at the end of surgery. Both drugs increased heart rate and midazolam also decreased diastolic blood pressure. The two drugs caused significant, equal increases in ratings of sedation, but the reduction of anxiety was significant only for midazolam. There was significant amnesia for material presented after drug administration, as well as for dental events and this was significantly greater for midazolam. The effects of these drugs in dental patients were compared with those in normal volunteers treated in an identical manner, but without oral surgery. The drugs had similar significant cardiovascular and amnesic effects in the volunteers and the same effects on mood ratings, even though volunteers and patients differed in their pretreatment levels of anxiety and discontent. The dentist's ratings of the sedation and operating conditions were excellent in both cases. Thus temazepam elixir provided a useful sedative for oral surgery, avoiding the complications of intravenous administration. However, for equivalent levels of sedation, midazolam had greater anxiolytic and amnesic effects than temazepam.

Administration, Oral↗

PubMed1984

Continuous transcutaneous oxygen monitoring in acutely ill preterm infants.

Twenty preterm infants in respiratory distress, each with an umbilical catheter in place, were studied during their first 24 h of hospitalization, to determine the effects of continuous transcutaneous oxygen (PtcO2) monitoring on the frequency of arterial blood gas (ABG) determinations and on the incidence of hypoxia and hyperoxia. PtcO2 was measured continuously in all infants during the 24-h period. By random allocation, PtcO2 data were withheld during either the 1st or 2nd 12-h period of hospitalization from clinicians caring for the infant. Comparison of the 12-h period in which PtcO2 data were available (open TcM) with the period in which they were withheld showed no difference in the number of ABG determinations (6.3 +/- 0.6 vs 7.4 +/- 1.0/12 h). During the open TcM period, there was significantly less hypoxia (PtcO2 less than 50 torr) (9.0 +/- 3.7% vs 16.3 +/- 4.2%, p less than .025) but no difference in hyperoxia (PtcO2 greater than 100 torr). Although continuous PtcO2 monitoring in acutely ill newborns did not decrease the frequency of ABG determinations, it may lessen morbidity by decreasing the amount of hypoxia infants experience while being stabilized early in hospitalization.

Acute Disease↗

PubMed1983

Intestinal bypass. A randomized, prospective clinical study of end-to-side and end-to-end jejunoileal bypass.

Of 21 patients with morbid obesity 10 were randomly allocated to ES (end-to-side) and 11 to EE (end-to-end) jejunoileal bypass. Ten patients in each group were followed up for more than 3 years. Average weight loss 18 months after operation was 37 kg or 33% of preoperative body weight in the ES group and 40 kg or 37% in the EE group (p = 0.26). One year after operation the mean serum concentration of magnesium was 0.84 mmol/l in the ES group and 0.66 in the EE group (p = 0.02), and the serum concentration of folic acid was 11.5 nmol/l in the ES group and 6.0 in the EE group (p = 0.01). The liver biopsies showed significant (p = 0.01) increased steatosis 1 year after operation in the EE group compared with peroperative biopsies, and the difference between the two groups at the 12-month follow-up almost reached statistical significance in favour of the ES group (p = 0.07). In the EE group, interposition of an intestinal segment was performed in 4 patients 17-27 months after the primary operation because of electrolyte deficiency and/or ulcer in the ileocolic anastomosis. The results in this series indicate that the ES shunt is a better operation than the EE shunt.

Adult↗

PubMed2004

A comparison of nebulized budesonide, and intramuscular, and oral dexamethasone for treatment of croup.

OBJECTIVES: Croup or acute laryngotracheobronchitis is the most common cause of the upper airway obstruction. Cool mist, nebulized racemic epinephrine and steroids are commonly used for therapy. Although steroid treatment can be applied orally, in nebulized form, or parenterally, no study has compared these three regimens yet. In this study, the efficacy of nebulized budesonide, and oral and intramuscular dexamethasone are compared for treatment of croup. STUDY DESIGN: Sixty children aged 6-36 months were randomly allocated into four groups. The first three study groups (15 children in each) took nebulized budesonide, oral dexamethasone and intramuscular dexamethasone, respectively, in addition to salbutamol and other supportive measures and these were compared with the placebo group. All patients were evaluated with "Westley Croup Score" on admission to pediatric emergency department (0h) and at 24, 48 and 72h. RESULTS: At the end of the study, the croup scores of all steroid treatment groups were significantly lower than the placebo group, but there was no statistical difference among them. CONCLUSIONS: Nebulized budesonide, oral and parenteral dexamethasone have the same effectiveness for treatment of croup and the choice depends on conditions of the patient and the physician.

Administration, Intranasal↗

PubMed1980

Sulphinpyrazone in acute myocardial infarction: studies on cardiac rhythm and renal function.

Ninety-eight patients with acute myocardial infarction were randomly allocated to receive sulphinpyrazone 200 mg four times daily or placebo on admission to a coronary care unit. Twenty-four-hour electrocardiogram tape recordings showed no significant reduction in serious arrhythmias in the sulphinpyrazone-treated group. In addition to the expected all in serum urate concentration, patients taking sulphinpyrazone showed a persistent increase in their serum urea and creatinine concentrations when compared with those in the placebo groups (p < 0.05 and p < 0.01 respectively). These differences could not be accounted for by differences in the extent and severity of the infarction between the two groups. These results suggest that sulphinpyrazone has no discernible antiarrhythmic effect in acute myocardial infarction.

Arrhythmias, Cardiac↗

PubMed1985

Ceftazidime as first-line therapy for fever in acute leukaemia.

Fifty patients with acute non-lymphocytic leukaemia were treated by random allocation with either ceftazidime alone or a combination of piperacillin, netilmicin and cefotaxime for 65 febrile neutropenic episodes. Nineteen of 33 patient episodes (58%) responded to ceftazidime alone compared with 21 of 32 episodes (66%) treated with the combination. There was one infective death in a patient given the combination; rates of documented superinfection were low. The treatment groups appeared identical in terms of patient demography, underlying disease and other risk factors, though patients with a clinical site of infection responded more slowly than those without. Bacteraemia per se did not appear to influence outcome. Bactericidal serum concentrations greater than or equal to 8 X the minimum bactericidal concentration were predictive of a rapid response (within 4 days) to antibiotics. Furthermore, serum from patients treated with ceftazidime maintained adequate cidal activity against Pseudomonas aeruginosa for longer than that obtained from patients treated with the three-drug combination. Ceftazidime was shown to be a safe and effective alternative to the three-drug combination for the initial management of febrile neutropenic episodes in leukaemic patients.

Adolescent↗

PubMed1989

Randomized trial of a low-molecular-weight heparin (Kabi 2165) versus adjusted-dose subcutaneous standard heparin in the prophylaxis of deep-vein thrombosis after elective hip surgery.

124 patients undergoing total hip replacement were randomly allocated to receive Kabi 2165, 2,500 anti-Xa units twice a day (group A); Kabi 2165, 2,500 anti-Xa units twice a day during the first 48 h postoperatively and then 5,000 anti-Xa units once a day (group B), or adjusted-dose standard heparin, monitored by activated partial thromboplastin time (group C). The first dose was given 2 h before surgery in the three groups. Deep-vein thrombosis (DVT) was detected by radiolabelled fibrinogen uptake and bilateral venography was performed in patients who had a positive scan. In patients who had a negative scan, bilateral venography was performed routinely the day before discharge from hospital. The frequency of DVT demonstrated by venography was 4.9% in group A, 7.3% in group B and 10% in group C. The difference between the three groups was not statistically significant. The incidence of proximal DVT was 2.4, 2.4 and 7.5%, respectively, for the three groups. There was no significant difference between the three groups with respect to mean estimated blood loss, the number of blood units transfused, wound hematoma formation, or hemoglobin and hematocrit levels.

Drug Evaluation↗

PubMed1987

Canadian multicenter randomized trial comparing sequential and alternating administration of two non-cross-resistant chemotherapy combinations in patients with limited small-cell carcinoma of the lung.

In order to assess the effect of scheduling of chemotherapy on the outcome of patients with limited small-cell lung cancer (SCLC), the Clinical Trials Group of the National Cancer Institute of Canada carried out a randomized trial comparing the alternation of cyclophosphamide, Adriamycin (Adria Laboratories, Columbus, OH; doxorubicin) and vincristine (CAV) with etoposide (VP-16) and cisplatin for six cycles to the administration of these two combinations in a sequential fashion (three cycles of CAV followed by three of VP-16/cisplatin). Three hundred eligible patients were enrolled on the trial from September 1981 to October 1984. All responding patients were also treated after completion of chemotherapy with thoracic irradiation in randomly allocated doses of 2,000 and 3,750 cGy. The complete response (CR) rate to chemotherapy was slightly, but not significantly, higher on the alternating arm (52% v 44%, P = .20). However, there was no difference in disease-free or overall survival on the alternating and sequential arms, respectively (47.3 weeks v 45.1 weeks, P = .26; 61.7 weeks v 59.5 weeks, P = .56). Data on the effect of radiotherapy dose on survival are not yet mature, but it does not appear the results of this portion of the trial will alter the interpretation of the chemotherapy comparison. Patient characteristics favorably influencing survival were female sex, good performance status, younger age, and absence of supraclavicular node involvement. Two interpretations of these and other results in SCLC are suggested: (1) the difference between the schedules used is too small for the predictions of the Goldie-Coldman model to be realized in a trial of this size, or (2) VP-16/cisplatin is actually a superior regimen and any schedule that exposes patients to these drugs early in treatment will produce improved results.

Adult↗

PubMed1984

Comparison of intubating conditions with atracurium, vecuronium and pancuronium.

A blind trial, comparing time of onset of satisfactory conditions for tracheal intubation with atracurium 0.6 mg/kg, vecuronium 0.1 mg/kg and pancuronium 0.1 mg/kg is described. Intubation was attempted at 30-second intervals in 60 patients, randomly allocated to receive one of the above muscle relaxants. Patients receiving atracurium 0.6 mg/kg could be intubated from 30 to 120 seconds. Patients receiving either vecuronium 0.1 mg/kg or pancuronium 0.1 mg/kg were able to be intubated between 60 and 240 seconds. The results showed a statistically significant earlier onset of satisfactory intubating conditions with atracurium than with vecuronium or pancuronium in these doses but no difference between vecuronium and pancuronium.

Adolescent↗

PubMedDate not supplied

Comparison of the therapeutic response of patients with childhood acute lymphoblastic leukemia in relapse to vindesine versus vincristine in combination with prednisone and L-asparaginase: a phase III trial.

One hundred and seventy-nine previously treated children with acute lymphoblastic leukemia in relapse considered not "resistant" to vincristine (VCR) were randomly allocated to receive reinduction therapy with either vindesine (VND) or VCR, in combination with prednisone and L-asparaginase. Complete remission rates were 57% for both regimens and were significantly greater for first relapsers (69%) than for subsequent relapsers (43%). No significant difference in response rates by regimen was observed within relapse groups. Patients treated with VND experienced significantly greater hematologic toxicity. These data suggest that there is no advantage to using VND instead of VCR in standard reinduction therapy for childhood acute lymphoblastic leukemia in relapse.

Asparaginase↗

PubMed1988

Single dose gentamicin treatment of urinary infections in children.

Sixty-nine children with urinary tract infections were randomly allocated to single dose gentamicin therapy (n = 39) or a seven day course of an appropriate antibiotic (n = 30). During the following six weeks the response to treatments did not differ and this was not altered by the child's clinical diagnosis, past history of infection or presence of radiological abnormalities. The poorest response was in those children with a history of recurrent infections (p less than 0.01) and/or radiological abnormality (p less than 0.02). Single dose therapy had significantly less suppression upon rectal (p less than 0.001) and periurethral (p less than 0.02) flora. There was a tendency for those not cured by single dose treatment to relapse whereas those treated by conventional therapy tended to be reinfected.

Acute Disease↗

PubMed1986

Prognostic factors in patients with brain metastases from lung carcinoma.

Between September 1980 to December 1983, 70 consecutive patients were entered into two randomly allocated trials in order to investigate the effectiveness of different time-dose radiotherapy schemes (i.e., 30 Gy/ten fractions/two weeks versus 50 Gy/20 fractions/four weeks) and the prognostic factors on the palliation for patients with brain metastases from lung carcinoma. The most important factors for predicting poor prognosis in this series, which were shown by stepwise proportional hazard (Cox) model, were lactate dehydrogenase (LDH) and general performance status. In normal LDH group, the most important factors for predicting poor prognosis were multiplicity of brain metastases (p less than 0.001), treatment methods (p less than 0.0005) and age (p less than 0.0053). In high LDH group any items were not shown for meeting of the 0.05 significant level.

Age Factors↗

PubMed1984

Randomized phase II trial of carminomycin versus 4'-epidoxorubicin in advanced breast cancer.

Sixty-three evaluable patients with advanced breast cancer were randomly allocated to receive three-week intravenous courses of carminomycin (18 mg/m2) or 4'-epidoxorubicin (90 mg/m2). The former yielded one (3%) partial response for nine weeks among 29 patients whereas, in the other arm, nine (27%) of 34 patients achieved partial response for a median of 28 weeks (range, nine to 36 weeks; p less than 0.02). The major toxic effect of these anthracyclines was leukopenia with median white blood cell nadirs of 1,600/microL (range, 300-4,000/microL) versus 1,800/microL (range, 500-4,300/microL), respectively. Acute nonhematologic toxic effects were qualitatively similar but carminomycin produced significantly less gastrointestinal intolerance and alopecia. Patients whose disease failed to respond to first-line anthracycline received doxorubicin (60 mg/m2) every three weeks. Four partial responses were obtained among 19 patients previously treated with carminomycin. Following 4'-epidoxorubicin therapy, one of 12 evaluable patients also attained partial response. Survival curves were not affected by the initial treatment option. Carminomycin has marginal activity against breast cancer whereas 4'-epidoxorubicin deserves further evaluation of its therapeutic index relative to doxorubicin. The design used in this trial appears attractive for prompt phase II evaluation of anthracycline analogs.

Adult↗

PubMed1991

A randomized clinical trial to compare two different approaches in women with chronic pelvic pain.

One hundred six patients with chronic pelvic pain were randomly allocated to one of two treatment groups. In the standard-approach group, organic causes of pelvic pain were excluded first and diagnostic laparoscopy was routinely performed. If no somatic cause could be found, attention was given to other causes such as psychological disturbances. In the second group an integrated approach was chosen. From the beginning equal attention was devoted to somatic, psychological, dietary, environmental, and physiotherapeutic factors. In this group, laparoscopy was not routinely performed. Both groups were similar with respect to clinical characteristics of the patients and the severity of their pain as assessed by various pain parameters. Postcoital pain was reported by 27% of the patients. Twenty percent of the patients had had negative sexual experiences such as childhood sexual abuse or rape. Evaluation of the pain 1 year after the institution of treatment revealed that the integrated approach improved pelvic pain significantly more often than the standard approach for three out of four pain parameters (P less than .01). Laparoscopy played no important role in the treatment of pelvic pain. It is concluded that equal attention to both organic and other causative factors from the beginning of therapy is more likely to result in a reduction of pelvic pain than is a standard approach.

Adolescent↗