Randomised controlled trial comparing oral and intravenous rehydration therapy in children with diarrhoea. A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose. A comparative trial of rapid oral and intravenous rehydration in acute diarrhoea. Multimodal antiemetic management prevents early postoperative vomiting after outpatient laparoscopy. Oral versus intravenous rehydration therapy in severe gastroenteritis. Multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of a reduced osmolarity oral rehydration salts solution in children with acute watery diarrhea. Efficacy of standard glucose-based and reduced-osmolarity maltodextrin-based oral rehydration solutions: effect of sugar malabsorption. Effect on clinical outcome of breast feeding during acute diarrhoea.
To determine the effectiveness of oral rehydration in children with moderate dehydration caused by gastroenteritis, and to compare the complications of oral and intravenous treatment.
                Randomised controlled trial.
                Emergency department and infectious diseases ward in a large urban teaching hospital.
                111 children aged 3-36 months who had been previously healthy, had had diarrhoea for seven days or less, had clinical signs of dehydration, and were not in shock. Six children were withdrawn because the diagnosis was incorrect (four in oral group, two in intravenous group) and one (oral group) was withdrawn at her parents' request.
                Oral rehydration fluid was given by mouth or nasogastric tube, or both to 52 children. The remaining 52 received intravenous rehydration fluids but were allowed to drink.
                Success or failure of rehydration. Number of times child vomited or passed stool after starting treatment. Time taken to rehydrate.
                Oral treatment failed in two children (failure rate 3.8%, upper 95% confidence limit 11.6%) and intravenous treatment in none. Vomiting was more common in the oral group (p less than 0.01): 26 of 50 children (52%) in the oral group and 11 of 50 (22%) in the intravenous group vomited during rehydration. There was no significant difference between the two treatment groups in the number of stools passed during rehydration (p = 0.09). None of the children had serious complications of treatment.
                Rehydration by mouth or nasogastric tube is a safe and effective treatment for moderately dehydrated children with gastroenteritis. To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea.
                One hundred ninety boys, aged 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours.
                In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 +/- 6 mEq/L) than in children receiving the standard WHO ORS (138 +/- 7 mEq/L) (p < 0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups.
                The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea. 37 children under the age of 5 years hospitalized for acute diarrhoea and dehydration were randomized to receive oral or intravenous rehydration during 6 to 12 hours. Rehydration was satisfactory in both groups, with correction of dehydration, metabolic acidosis and sodium deficit at equal rates. The reintroduction of normal feedings was successful in most of the orally rehydrated children after 12 hours, but often unsuccessful in the i.v. therapy group. Consequently the orally rehydrated children showed a 2.9% weight gain by the time of discharge whereas the intravenously treated children did not gain weight in the hospital. The duration of diarrhoea was also shorter in the orally rehydrated children. Thus oral rehydration therapy was equal or superior to even rapid intravenous rehydration therapy in the management of acute diarrhoea in children. Because no completely effective antiemetic exists for the prevention of postoperative nausea and vomiting (PONV), we hypothesize that a multimodal approach to management of PONV may reduce both vomiting and the need for rescue antiemetics in high-risk patients. After IRB approval, women undergoing outpatient laparoscopy were randomized to one of three groups. Group I (n = 60) was managed by using a predefined multimodal clinical care algorithm. Patients undergoing the same surgical procedure who received a standard balanced outpatient anesthetic with ondansetron 4 mg (Group II, n = 42) or placebo (Group III, n = 37) prophylaxis were chosen to establish baseline incidence of nausea and vomiting. None of the Group I patients vomited before discharge, compared with 7% in Group II (P = 0.07) and 22% in Group III (P = 0.0003). However, one patient (2%) in Group I required treatment for symptoms in the postanesthesia care unit, compared with 24% in Group II (P<0.0001) and 41% in Group III (P< 0.0001). Time to discharge-ready was significantly shorter in Group I (128, 118-139 min; mean, 95% confidence interval) versus Group II (162, 145-181 min; P = 0.0015) and Group III (192, 166-222 min; P = 0.0001). Patient satisfaction with control of PONV was not different between Group I and Group II. Return to normal daily activity and overall satisfaction were not different among groups. Multimodal management resulted in a 98% complete response rate and a 0% incidence of vomiting before discharge; however, this improvement did not result in an increased level of patient satisfaction when compared with routine monotherapy prophylaxis. We conclude that both multimodal management and routine monotherapy antiemetic prophylaxis resulted in an increased level of patient satisfaction than symptomatic treatment in this high-risk population. A controlled, randomised trial comparing the results of oral rehydration therapy with those of intravenous fluid treatment in 470 children with severe gastroenteritis was undertaken. The oral rehydration therapy was divided into two phases--a rehydration phase that used high sodium isotonic fluid at 40 ml/kg per hour and a maintenance phase using low sodium isotonic fluid (sodium 40, potassium 30, bicarbonate 25, chloride 45, and dextrose 130 mmol/l). The results indicate that oral rehydration treatment, used according to this protocol, is successful in treating severe diarrhoea and dehydration, and has considerable advantages over intravenous fluid therapy in reducing complications associated with the treatment of hypernatraemia, in promoting rapid correction of hypokalaemia and acidosis, in decreasing the duration of diarrhoea, and in promoting a greater weight gain at hospital discharge. To compare the efficacy of a reduced osmolarity oral rehydration salts (ORS) solution (75 mmol/L of sodium [Na], 20 mmol/L of potassium [K], 65 mmol/L of chloride, 10 mmol/L of citrate, and 75 mmol/L of glucose; osmolarity, 245 mosm/L) with that of the standard World Health Organization (WHO) ORS solution.
                A multicenter, double-blind, randomized, controlled clinical trial conducted in children with acute diarrhea in 5 developing countries to measure mean stool output in the 24 hours after randomization, proportion of children who required unscheduled intravenous therapy, proportion of children who vomited in the first 24 hours, and diarrhea duration after randomization.
                A total of 675 children who ranged in age from 1 to 24 months and who had acute diarrhea and dehydration were enrolled in the trial; 341 were randomized to receive reduced osmolarity ORS solution, and 334 were randomized to receive the WHO ORS solution. The mean (SE) stool output (g/kg) in the first 24 hours (reduced osmolarity ORS solution vs WHO ORS solution = 114 [4] vs 125 [5]) and during the total study period (reduced osmolarity ORS solution vs WHO ORS solution = 320 [18] vs 331 [18]) were comparable. The proportion of children who vomited in the first 24 hours (reduced osmolarity ORS solution vs WHO ORS solution = 58% vs 62%) and the diarrhea duration in the 2 treatment groups, compared by log rank test, were similar. The proportion of children who required unscheduled intravenous therapy was significantly lower in children who received reduced osmolarity ORS solution (10%) as compared with those who received the WHO ORS solution (15%; odds ratio = 0.6, 95% confidence interval = 0.4-1.0). There was no significant difference in the incidence of hyponatremia (serum Na <130 mmol/L) at 24 hours between the 2 treatment groups (11% in reduced osmolarity ORS solution group vs 9% in the WHO ORS solution group; odds ratio = 1.3; 95% confidence interval = 0.8-2.2). The frequency of patients with serum Na <125 mmol/L at 24 hours was 13 of 341 (4%) in children who were treated with reduced osmolarity ORS solution versus 7 of 334 (2%) in children who received the WHO ORS solution.
                Treatment with reduced osmolarity ORS solution was associated with a 33% reduction in the need for unscheduled intravenous therapy and had no apparent effect on stool output and illness duration when compared with treatment with the standard WHO ORS solution. Children with acute diarrhea, therefore, may benefit from a reduced osmolarity ORS solution. The results of trials that examine the efficacy and safety of reduced osmolarity ORS solution in adult patients with cholera have to be taken into consideration before consensus on composition of oral rehydration formulation can be reached. Previously we reported that standard oral rehydration salts (ORS) solution is not as effective as a reduced-osmolarity glucose-based ORS for the treatment of children with acute noncholera diarrhoea: with standard ORS the diarrhoea lasts longer, stool output is greater, serum sodium is higher, and there is more need for supplemental intravenous infusion. We studied a reduced-osmolarity maltodextrin (MD)-based ORS to determine whether it had similar benefits, and also the effect of sugar malabsorption on the efficacy of standard and MD-based ORS. A total of 90 boys aged 3-24 months with acute noncholera diarrhoea and moderate dehydration were randomly assigned to either standard ORS (glucose 20 g/l, osmolarity 311 mmol/l) or MD-ORS (MD 50 g/l, osmolarity 227 mmol/l). There were no differences in treatment results. Some 46% of subjects had a high total stool output (> 300 g/kg), which was unrelated to the type of ORS given. High stool output was significantly associated with a longer duration of diarrhoea (33 vs. 15 hours; P < 0.001), a persistently elevated serum sodium (149 vs. 144 mmol/l at 24 h; P < 0.02), the need for intravenous infusion (11/41 vs. 0/48; P < 0.002), and an increase in faecal reducing substances (10.8 vs. 3.4 g/l at 24 h; P < 0.001). We conclude that some children given standard ORS develop osmotic diarrhoea owing to the combined effect of transient sugar malabsorption and slight hypertonicity of the ORS. Earlier studies show that this adverse outcome can largely be avoided when extra water is given in reduced-osmolarity glucose-based ORS. Reduced osmolarity has no benefit, however, when glucose is replaced by maltodextrin, probably because the sugars released by hydrolysis of MD, when malabsorbed, raise the intraluminal osmolarity to equal or exceed that of standard ORS. Thus, reduced-osmolarity glucose-based ORS is superior to both standard ORS and reduced-osmolarity solutions based on maltodextrin and probably other complex carbohydrates. Studies are in progress to define the optimal formulation of reduced-osmolarity glucose-based ORS. The effects of oral rehydration fluid alone and of oral rehydration fluid plus breast feeding on the course and outcome of acute diarrhoea were assessed in two groups of 26 children aged under 2 years. Children who continued to be breast fed during treatment with oral rehydration solutions passed significantly fewer diarrhoeal stools. They also passed, on average, a smaller volume of diarrhoeal stools and recovered from diarrhoea sooner after the start of treatment. Their requirement for oral rehydration fluid was significantly reduced. Breast feeding exerts a beneficial effect on the course and outcome of acute diarrhoea by reducing the number and volume of diarrhoeal stools.
There was no evidence that early refeeding increases the risk of unscheduled intravenous fluid use, episodes of vomiting, and development of persistent diarrhoea. No conclusion could be made regarding the duration of diarrhoea.