Oral versus intravenous rehydration of moderately dehydrated children: a randomized, controlled trial. A randomized trial of oral vs intravenous rehydration in a pediatric emergency department. Oral and intravenous rehydration of children. An RCT pilot study to test the effects of intravenous midazolam as a conscious sedation technique for anxious children requiring dental treatment--an alternative to general anaesthesia. Intra-arterial or intravenous thrombolysis for acute ischemic stroke? The SYNTHESIS pilot trial. Treatment of postoperative paralytic ileus by intravenous lidocaine infusion. A randomized trial comparing peripherally inserted central venous catheters and peripheral intravenous catheters in infants with very low birth weight. Postoperative management of cesarean patients: the effect of immediate feeding on the incidence of ileus. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barré syndrome: a randomized study. Randomised controlled trial comparing oral and intravenous rehydration therapy in children with diarrhoea. Oral versus initial intravenous therapy for urinary tract infections in young febrile children. Effects of immediate modified feeding on infantile gastroenteritis. Food-based oral rehydration salt solution for acute childhood diarrhoea. A randomized study of closure of the peritoneum at cesarean delivery.
Dehydration from viral gastroenteritis is a significant pediatric health problem. Oral rehydration therapy (ORT) is recommended as first-line therapy for both mildly and moderately dehydrated children; however, three quarters of pediatric emergency medicine physicians who are very familiar with the American Academy of Pediatrics recommendations for ORT still use intravenous fluid therapy (IVF) for moderately dehydrated children.
                To test the hypothesis that the failure rate of ORT would not be >5% greater than the failure rate of IVF. Secondary hypotheses were that patients in the ORT group will (1) require less time initiating therapy, (2) show more improvement after 2 hours of therapy, (3) have fewer hospitalizations, and (4) prefer ORT for future episodes of dehydration.
                A randomized, controlled clinical trial (noninferiority study design) was performed in the emergency department of an urban children's hospital from December 2001 to April 2003. Children 8 weeks to 3 years old were eligible if they were moderately dehydrated, based on a validated 10-point score, from viral gastroenteritis. Patients were randomized to receive either ORT or IVF during the 4-hour study. Treating physicians were masked and assessed all patients before randomization at 2 and 4 hours of therapy. Successful rehydration at 4 hours was defined as resolution of moderate dehydration, production of urine, weight gain, and the absence severe emesis (> or =5 mL/kg).
                Seventy-three patients were enrolled in the study: 36 were randomized to ORT and 37 were randomized to IVF. Baseline dehydration scores and the number of prior episodes of emesis and diarrhea were similar in the 2 groups. ORT demonstrated noninferiority for the main outcome measure and was found to be favorable with secondary outcomes. Half of both the ORT and IVF groups were rehydrated successfully at 4 hours (difference: -1.2%; 95% confidence interval [CI]: -24.0% to 21.6%). The time required to initiate therapy was less in the ORT group at 19.9 minutes from randomization, compared with 41.2 minutes for the IVF group (difference: -21.2 minutes; 95% CI: -10.3 to -32.1 minutes). There was no difference in the improvement of the dehydration score at 2 hours between the 2 groups (78.8% ORT vs 80% IVF; difference: -1.2%; 95% CI: -20.5% to 18%). Less than one third of the ORT group required hospitalization, whereas almost half of the IVF group was hospitalized (30.6% vs 48.7%, respectively; difference: -18.1%; 95% CI: -40.1% to 4.0%). Patients who received ORT were as likely as those who received IVF to prefer the same therapy for the next episode of gastroenteritis (61.3% vs 51.4%, respectively; difference: 9.9%; 95% CI: -14% to 33.7%).
                This trial demonstrated that ORT is as effective as IVF for rehydration of moderately dehydrated children due to gastroenteritis in the emergency department. ORT demonstrated noninferiority for successful rehydration at 4 hours and hospitalization rate. Additionally, therapy was initiated more quickly for ORT patients. ORT seems to be a preferred treatment option for patients with moderate dehydration from gastroenteritis. Physicians report several barriers to the use of oral rehydration therapy (ORT) for dehydration in children due to acute gastroenteritis.
                To compare ORT with intravenous therapy for the treatment of moderate dehydration in children with acute gastroenteritis and to determine whether the factors reported as barriers to the use of ORT would be substantiated in practice.
                Randomized controlled trial in an urban pediatric emergency department. Children with moderate dehydration due to acute gastroenteritis were randomly assigned to ORT (group 1) or intravenous therapy (group 2). The primary outcome was length of stay in the emergency department. Secondary outcomes included hospital admission rate, staff time, relapse after discharge from the hospital, and parental satisfaction. Two days after discharge, parents were surveyed by telephone to assess the relapse and their satisfaction with the visit.
                Eighteen patients were enrolled in group 1 and 16 in group 2. The mean length of stay in group 1 was 225 vs 358 minutes in group 2 (P<.01). Mean staff time was 35.8 minutes in group 1 compared with 65 minutes in group 2 (P =.03). Three patients failed ORT and required intravenous therapy. Two patients (11%) in group 1 vs 4 (25 %) in group 2 required admission to the hospital (P =.20). No patients relapsed after being discharged from the hospital. Fourteen parents (77%) in group 1 compared with 6 (37.5%) in group 2 reported that they were highly satisfied with all aspects of the visit (P =.01).
                Reported barriers to ORT were not supported by our data. Moreover, ORT performed better than intravenous therapy on all measured outcomes. We compared oral rehydration therapy (ORT) with rapid intravenous rehydration (IV) in 42 young children with mild to moderate dehydration due to diarrhea. Overall, treatment was successful for 82% of the ORT patients and for 78% of the IV patients. Many physicians in hospitals are unfamiliar with the use of ORT for treating dehydration. To add to the evidence base for acceptable and effective paediatric conscious sedation techniques in dental primary care.
                To compare three conscious sedation techniques for primary care as an alternative to dental general anaesthesia (DGA) in children. To assess the feasibility and practicality of running the trial in general dental practice. To form the basis for sample size calculations and assess scales of measurement.
                Single centre, randomised control trial (RCT).
                Queensway Anxiety Management Clinic (QAMC). A primary care based general and referral dental practice for the management of anxious patients.
                Sixty five children too anxious for management with relative analgesia, requiring invasive dental procedure for which dental general anaesthesia (DGA) will be required if an alternative cannot be found.
                Group 1 (n = 20) - A combination of inhaled medical air and titrated intravenous midazolam. Group 2 (n = 22) - A combination of inhaled 40% nitrous oxide in oxygen and titrated intravenous midazolam. Group 3 (n = 23) - A combination of an inhaled mixture of 0.3% sevoflurane and 40% nitrous oxide in oxygen with titrated intravenous midazolam.
                Successful completion of the intended dental treatment with a child who is co-operative and responsive to verbal commands.
                Fifty per cent (ten children) successfully completed treatment in Group 1, 73% (16 children) in Group 2 and 83% (19 children) in Group 3. This difference was not significant at a 5% level (chi(2) = 5.53, df = 2, P = 0.07) Of the total of 20 failures, eight children in Group 1 and one child in Group 2 were successfully treated with the addition of sevoflurane and nitrous oxide in oxygen. Only two children required referral to a hospital setting for DGA and the remaining nine children were managed with an alternative conscious sedation technique.
                This pilot shows that intravenous midazolam especially in combination with the addition of inhaled nitrous oxide or sevoflurane and nitrous oxide were promising safe and effective techniques, sufficient to justify progression to a definitive RCT with appropriate methods. OBJECTIVE To assess the feasibility, safety and preliminary efficacy of intra-arterial thrombolysis (IAT) compared with standard intravenous thrombolysis (IVT) for acute ischemic stroke. METHODS Eligible patients with ischemic stroke, who were devoid of contraindications, started IVT within 3 h or IAT as soon as possible within 6 h. Patients were randomized within 3 h of onset to receive either intravenous alteplase, in accordance with the current European labeling, or up to 0.9 mg/kg intra-arterial alteplase (maximum 90 mg), over 60 min into the thrombus, if necessary with mechanical clot disruption and/or retrieval. The purpose of the study was to determine the proportion of favorable outcome at 90 days. Safety endpoints included symptomatic intracranial hemorrhage (SICH), death and other serious adverse events. RESULTS 54 patients (25 IAT) were enrolled. Median time from stroke onset to start to treatment was 3 h 15 min for IAT and 2 h 35 min for IVT (p<0.001). Almost twice as many patients on IAT as those on IVT survived without residual disability (12/25 vs 8/29; OR 3.2; 95% CI 0.9 to 11.4; p=0.067). SICH occurred in 2/25 patients on IAT and in 4/29 on IVT (OR 0.5; CI 0.1 to 3.3; p=0.675). Mortality at day 7 was 5/25 (IAT) compared with 4/29 (IVT) (OR 1.6; CI 0.4 to 6.7; p=0.718). There was no significant difference in the rate of other serious adverse events. CONCLUSIONS Rapid initiation of IAT is a safe and feasible alternative to IVT in acute ischemic stroke. The effects of continuous intravenous infusion of lidocaine on postoperative paralytic ileus in cholecystectomized patients was investigated in this double-blind study. An infusion of lidocaine (3 mg/min, n = 15) or an infusion of an equal volume of saline (n = 15) was started 30 min before induction of anesthesia and continued for 24 h after surgery. Postoperative colonic motility was evaluated by radiopaque markers and serial abdominal radiographs. A record was kept of the first passage of gas and feces. Results showed significantly earlier return of propulsive motility in the colon of lidocaine-treated patients. Radiopaque markers in the lidocaine group were propelled significantly earlier from the cecum/ascending colon to the transverse colon (P less than 0.05) and appeared significantly earlier in the descending colon (P less than 0.05) and the rectosigmoid colon (P less than 0.05) than in saline-treated patients. Despite the fact that the mean time for postoperative defecation occurred 17 h earlier in lidocaine-treated patients, differences between the groups were not statistically significant--a fact due, perhaps, to great individual variations in defecation habits. The time to first passage of gas, a variable representative of changes in anorectal or colonic tone rather than propagative motility, also did not differ significantly between the groups. No adverse reactions to lidocaine were reported. The results suggest that continuous intravenous infusion of lidocaine during the first postoperative day shortens the duration of paralytic ileus in the colon after abdominal surgery. Suppression of inhibitory gastrointestinal reflexes by reduction of postoperative peritoneal irritation is suggested as the mechanism of action. To determine whether percutaneously inserted central venous catheters (PICC) and peripheral intravenous catheters (PIV) in infants with very low birth weight (VLBW) differ with respect to (1) incidence of sepsis, (2) number of insertion attempts and catheters required for total intravenous therapy, (3) courses of antibiotics, and (4) total duration of intravenous (IV) use.
                A randomized comparative trial was conducted involving 63 VLBW infants (<1,251 g) who required IV therapy. Infants were assigned randomly at 1 week of age to either a PIV or a PICC catheter and followed up prospectively until an IV was no longer required or the infant was transferred out of the neonatal intensive care unit.
                Data were analyzed on an intention-to-treat basis. There was no difference in the incidence of sepsis (P = .64), number of courses of antibiotics (P = .16), or total duration of IV use (P= .34) between the 2 groups. The number of insertion attempts required for total IV therapy was significantly lower in the PICC group than in the PIV group (P = .008). There also was a significantly lower number of total catheters utilized in the PICC group (P = .002). When data were controlled for birth weight strata the results were similar.
                PICC lines reduced the number of painful IV procedures in VLBW infants without additional morbidity. To evaluate the effect of immediate feeding on gastrointestinal function in patients undergoing cesarean delivery.
                A prospective study was conducted in which patients were randomized to one of two groups, either early feeding or delayed feeding, ie, feeding according to the institution's current protocol. Questionnaires were filled out by the subjects on the day of discharge. Fisher exact test was used to compare the two groups with respect to the type of anesthetic used and to compare the incidence of gastrointestinal symptoms. A one-sided exact binomial confidence interval was used to determine the upper bound of the likelihood of paralytic ileus. Logistic regression analysis was used to evaluate the presence of ileus symptoms when controlling for the type of anesthetic used.
                There were no significant differences between the control and study groups. There was no significant difference in the number of gastrointestinal symptoms between the two groups. The incidence of postoperative paralytic ileus was zero in both the study and control groups.
                Routine early feeding of subjects undergoing cesarean delivery can be implemented without an increase in gastrointestinal symptoms or paralytic ileus. Respiratory failure is a life threatening complication of Guillain Barré syndrome (GBS). There is no consensus on the specific treatment for this subset of children with GBS.
                This was a prospective randomized study to compare the outcome of intravenous immunoglobulin (IVIG) and plasma exchange (PE) treatment in children with GBS requiring mechanical ventilation. Forty-one children with GBS requiring endotracheal mechanical ventilation (MV) within 14 days from disease onset were included. The ages of the children ranged from 49 to 143 months.Randomly, 20 children received a five-day course of IVIG (0.4 g/kg/day) and 21 children received a five-day course of one volume PE daily. Lumbar puncture (LP) was performed in 36 patients (18 in each group).
                Both groups had comparable age (p = 0.764), weight (p = 0.764), duration of illness prior to MV (p = 0.854), preceding diarrhea (p = 0.751), cranial nerve involvement (p = 0.756), muscle power using Medical Research Council (MRC) sum score (p = 0.266) and cerebrospinal fluid (CSF) protein (p = 0.606).Children in the PE group had a shorter period of MV (median 11 days, IQR 11.0 to 13.0) compared to IVIG group (median 13 days, IQR 11.3 to 14.5) with p = 0.037.Those in the PE group had a tendency for a shorter Pediatric Intensive Care Unit (PICU) stay (p = 0.094).A total of 20/21 (95.2%) and 18/20 (90%) children in the PE and IVIG groups respectively could walk unaided within four weeks after PICU discharge (p = 0.606).There was a negative correlation between CSF protein and duration of mechanical ventilation in the PE group (p = 0.037), but not in the IVIG group (p = 0.132).
                In children with GBS requiring MV, PE is superior to IVIG regarding the duration of MV but not PICU stay or the short term neurological outcome.The negative correlation between CSF protein values and duration of MV in PE group requires further evaluation of its clinical usefulness.
                Clinicaltrials.gov Identifier NCT01306578. 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. The standard recommendation for treatment of young, febrile children with urinary tract infection has been hospitalization for intravenous antimicrobials. The availability of potent, oral, third-generation cephalosporins as well as interest in cost containment and avoidance of nosocomial risks prompted evaluation of the safety and efficacy of outpatient therapy.
                In a multicenter, randomized clinical trial, we evaluated the efficacy of oral versus initial intravenous therapy in 306 children 1 to 24 months old with fever and urinary tract infection, in terms of short-term clinical outcomes (sterilization of the urine and defervescence) and long-term morbidity (incidence of reinfection and incidence and extent of renal scarring documented at 6 months by 99mTc-dimercaptosuccinic acid renal scans). Children received either oral cefixime for 14 days (double dose on day 1) or initial intravenous cefotaxime for 3 days followed by oral cefixime for 11 days.
                Treatment groups were comparable regarding demographic, clinical, and laboratory characteristics. Bacteremia was present in 3.4% of children treated orally and 5.3% of children treated intravenously. Of the short-term outcomes, 1) repeat urine cultures were sterile within 24 hours in all children, and 2) mean time to defervescence was 25 and 24 hours for children treated orally and intravenously, respectively. Of the long-term outcomes, 1) symptomatic reinfections occurred in 4.6% of children treated orally and 7.2% of children treated intravenously, 2) renal scarring at 6 months was noted in 9.8% children treated orally versus 7.2% of children treated intravenously, and 3) mean extent of scarring was approximately 8% in both treatment groups. Mean costs were at least twofold higher for children treated intravenously ($3577 vs $1473) compared with those treated orally.
                Oral cefixime can be recommended as a safe and effective treatment for children with fever and urinary tract infection. Use of cefixime will result in substantial reductions of health care expenditures. Standard treatment of infants who are dehydrated as a result of acute gastroenteritis is to administer oral rehydration therapy (ORT). Traditionally, food has been withdrawn for 24-48 h, but there is no conclusive evidence that this is of any real benefit to the patient. Immediate modified feeding, in which an infant on ORT is not starved but administered a limited diet, may have benefits in the treatment of gastroenteritis, especially in children who are nutritionally compromised before they develop the illness.
                A pilot study was carried out to investigate the effects of giving infants suffering from acute gastroenteritis a limited modified diet in conjunction with ORT.
                Infants recruited into the study by their general practitioner or by a research doctor in the hospital casualty unit of Bristol Children's Hospital were randomly allocated to receive ORT with or without immediate modified feeding. The duration of diarrhoea, weight change, and incidence of vomiting and lactose intolerance were measured in both treatment groups, and the results were compared.
                Of the infants studied, 27 received ORT and immediate modified feeding, and 32 ORT alone. The duration of diarrhoea, and incidence of vomiting or lactose intolerance were no greater in the group receiving immediate modified feeding. Patients who received ORT and immediate modified feeding appeared to gain more weight than the infants who were starved for 24-48 h, but this difference was not statistically significant.
                Immediate modified feeding is safe and effective, and may have nutritional advantages over traditional ORT with starvation. A similar but multicentre study using unmodified diet, i.e. child's normal diet, is being carried out by a working group of The European Society of Paediatrics, Gastroenterology and Nutrition (ESPGAN). The efficacy in acute childhood diarrhoea of oral rehydration therapy (ORT) based on staple foods (maize, millet, wheat, sorghum, rice, or potato) was compared with that of standard ORT based on glucose. 266 children aged 1-5 years, with a history of acute diarrhoea for 48 h or less, moderate to severe dehydration, and no complications, were assigned to treatment with one of the food-based oral rehydration salt solutions (ORS) or standard ORS. The mean stool output over the first 24 h of treatment in the group receiving standard ORS was significantly higher than that of any other treatment group, and the groups receiving food-based ORT showed substantial reductions in stool output compared with the standard ORT group. Abnormalities in electrolyte concentrations were corrected in all treatment groups with similar efficiency. The digestibility of the food-based ORS was assessed by the stool pH, glucose content before and after acid hydrolysis, and osmolality; there were no significant differences between the standard ORS and food-based ORS groups. Food-based ORT should be more acceptable to users in developing countries since the mixtures are similar to traditional weaning foods and since, unlike standard ORT, it reduces stool output substantially. This study was conducted to test the hypothesis that nonclosure of the visceral and parietal peritoneum during low transverse cervical cesarean delivery is not associated with increased intraoperative or immediate postoperative complications. One hundred thirteen patients scheduled for low transverse cervical cesarean were randomized to either closure of both the visceral and parietal peritoneum with absorbable suture (N = 59) or no peritoneal closure (N = 54). Patients were cared for in the usual postoperative manner without reference to treatment group. There were no demographic differences between the groups and no differences in method(s) of anesthesia, operative indication(s), or use of peripartum epidural narcotics. The incidence of fever, endometritis, or wound infection was similar between groups. There were no differences in the number of patients requiring parenteral narcotic analgesia or in the number of doses per patient. The number of oral analgesic doses was significantly greater with closure than without (P = .014). The frequency with which postoperative ileus was diagnosed in each group was similar, and there was no difference regarding the day on which patients were advanced to liquid or select diets. Bowel stimulants were administered more frequently to the closure than to non-closure patients (P = .03). The average operating time was shorter for the open group than for the closure group (P less than .005). We conclude that non-closure of the visceral and parietal peritoneum at low transverse cervical cesarean delivery appears to have no adverse effect on immediate postoperative recovery, may decrease postoperative narcotic requirements, allows less complicated return of bowel function, and provides a simplified and shorter surgical procedure.
Although no clinically important differences between ORT and IVT, the ORT group did have a higher risk of paralytic ileus, and the IVT group was exposed to risks of intravenous therapy. For every 25 children (95% CI 14 to 100) treated with ORT one would fail and require IVT.