Background.Dehydration from viral gastroenteritis is a significant pediatric health problem.Oral rehydration therapy(ORT)is recommended as firstline thera py for both mildly and moderately dehydrated children;however,...Background.Dehydration from viral gastroenteritis is a significant pediatric health problem.Oral rehydration therapy(ORT)is recommended as firstline thera py for both mildly and moderately dehydrated children;however,three quarters o f pediatric emergency medicine physicians who are very familiar with the America n Academy of Pediatrics recommendations for ORT still use intravenous fluid ther apy(IVF)for moderately dehydrated children.Objective.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 l ess time initiating therapy,(2)show more improvement after 2 hours of therapy,(3)have fewer hospitalizations,and(4)prefer ORT for future episodes of dehy dration.Methods.A randomized,controlled clinical trial(noninferiority study design)was performed in the emergency department of an urban children’s hospit al from December 2001 to April 2003.Children 8 weeks to 3 years old were eligib le if they were moderately dehydrated,based on a validated 10-point score,fro m viral gastroenteritis.Patients were randomized to receive either ORT or IVF d uring the 4-hour study.Treating physicians were masked and assessed all patien ts 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(≥5 mL/kg).R esults.Seventy-three patients were enrolled in the study:36 were randomized t o 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 demon strated noninferiority for the main outcome measure and was found to be favorabl e with secondary outcomes.Half of both the ORT and IVF groups were rehydrated s uccessfully 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 a t 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 dif ference in the improvement of the dehydration score at 2 hours between the 2 gro ups(78.8%ORT vs 80%IVF;difference:-1.2%;95%CI:-20.5%to 18%).Less t han 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 thos e who received IVF to prefer the same therapy for the next episode of gastroente ritis(61.3%vs 51.4%,respectively;difference:9.9%;95%CI:-14%to 33.7%).Conclusions.This trial demonstrated that ORT is as effective as IVF for rehy dration of moderately dehydrated children due to gastroenteritis in the emergenc y department.ORT demonstrated noninferiority for successful rehydration at 4 ho urs and hospitalization rate.Additionally,therapy was initiated more quickly f or ORT patients.ORT seems to be a preferred treatment option for patients with moderate dehydration from gastroenteritis.展开更多
文摘Background.Dehydration from viral gastroenteritis is a significant pediatric health problem.Oral rehydration therapy(ORT)is recommended as firstline thera py for both mildly and moderately dehydrated children;however,three quarters o f pediatric emergency medicine physicians who are very familiar with the America n Academy of Pediatrics recommendations for ORT still use intravenous fluid ther apy(IVF)for moderately dehydrated children.Objective.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 l ess time initiating therapy,(2)show more improvement after 2 hours of therapy,(3)have fewer hospitalizations,and(4)prefer ORT for future episodes of dehy dration.Methods.A randomized,controlled clinical trial(noninferiority study design)was performed in the emergency department of an urban children’s hospit al from December 2001 to April 2003.Children 8 weeks to 3 years old were eligib le if they were moderately dehydrated,based on a validated 10-point score,fro m viral gastroenteritis.Patients were randomized to receive either ORT or IVF d uring the 4-hour study.Treating physicians were masked and assessed all patien ts 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(≥5 mL/kg).R esults.Seventy-three patients were enrolled in the study:36 were randomized t o 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 demon strated noninferiority for the main outcome measure and was found to be favorabl e with secondary outcomes.Half of both the ORT and IVF groups were rehydrated s uccessfully 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 a t 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 dif ference in the improvement of the dehydration score at 2 hours between the 2 gro ups(78.8%ORT vs 80%IVF;difference:-1.2%;95%CI:-20.5%to 18%).Less t han 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 thos e who received IVF to prefer the same therapy for the next episode of gastroente ritis(61.3%vs 51.4%,respectively;difference:9.9%;95%CI:-14%to 33.7%).Conclusions.This trial demonstrated that ORT is as effective as IVF for rehy dration of moderately dehydrated children due to gastroenteritis in the emergenc y department.ORT demonstrated noninferiority for successful rehydration at 4 ho urs and hospitalization rate.Additionally,therapy was initiated more quickly f or ORT patients.ORT seems to be a preferred treatment option for patients with moderate dehydration from gastroenteritis.
