Antiemetics for reducing vomiting related to acute ... - Update Software

NCT01165866 (Continued)
Participants Children 1 to 14 yrs, with diarrhea, persistent vomiting , failed oral rehydration and admitted to the observation
unit for intravenous hydration
Interventions Ondansetron 0.15 mg/kg max 4 mg in burette and mixed with normal saline to make up 50 cc of medication
and normal saline to be given over 10 minutes
Metoclopramide 0.3 mg/kg maximum dose 10 mg will be added in the burette and mixed with normal saline
to make up 50 cc of medication for intravenous administration
Outcomes Primary outcome measures: the proportion of patients with cessation of vomiting after study medication
administration in each group.
Secondary outcome measures: time to complete cessation of vomiting, time to successful oral therapy, length
of hospital stay, parents’ perception of the child, nausea symptoms, and oral tolerance on discharge and daily
follow-up for 3 days
Starting date June 2008
Contact information Khalid M Al-Ansari, Hamad Medical Corporation, Weill Cornell Medical College, Qatar. Email:
dkmaa@hotmail.com
Notes First received on July 18, 2010. Last Updated on October 25, 2010. Accessed 14 June 2011. Study completed
not yet published
NCT01257672
Trial name or title Symptomatic treatment of acute gastroenteritis
Methods RCT multi-centred Italy.
Participants Children (age 1-6 yrs) with AG who have failed oral rehydration therapy
Interventions • Ondansetron syrup (0.15 mg/kg of body weight).
• Domperidone syrup (0.5 mg/kg of body weight).
• Placebo.
Outcomes Primary outcome measures: percentage of patients needing nasogastric or intravenous rehydration after symptomatic
oral treatment failure, defined as vomiting or fluid refusal after the second attempt of ORT.
Secondary outcome measures: percentage of subjects needing hospital admission for the same illness.
Percentage of subjects needing observation stay for more than 6 hrs for the same illness.
Total emesis duration in the 3 allocation groups.
Number of episodes of vomiting in the 3 treatment groups during the follow-up period.
Percentage of subjects presenting adverse events.
Starting date March 2011. Accessed 14 June 2011, not yet recruiting.
Contact information IRCCS Burlo Garofolo (Dr. Federico Marchetti).
Mario Negri Institute for Pharmacological Research.
Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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