Introduction : Gastroenteritis is accompanied with high morbidity and mortality in pediatric patients. One of it’s complications is dehydration which should be managed perfectly. We evaluated the use of metoclopramide in control of vomiting in children with acute gastroenteritis and moderate dehydration.
Methods : in this double-blind randomized clinical trial study, we assigned 240 children aged 1-7 years old with vomiting due to Acute Viral Gastroenteritis to two groups of serum therapy(control) and metoclopramide(case).control group received 5% dextrose water solution along with electrolyte management while case group received 0.1 mg/kg Metoclopramide IV in addition. patients were followed for 4 days for number of vomiting episodes then data was analyzed using descriptive analysis , t-test and chi-square as appropriate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205159766N1
Registration date:2012-07-14, 1391/04/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-14, 1391/04/24
Registrant information
Name
Mohammadreza Firouzifar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7741 9732
Email address
src@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metoclopramide and serum therapy in control of vomiting in moderate dehydration due to Acute viral Gastroenteritis in children aged 1-7 years
Public title
Metoclopramide and serum therapy in control of vomiting in moderate dehydration due to Acute viral Gastroenteritis in children aged 1-7 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-7 year old children with acute viral gastroenteritis; vomiting; moderate isonatremic dehydration; parenteral intolerance; no therapy prior to admission; no need for therapies other than those provided and written consent by parents.
Exclusion criteria: mild or severe dehydration or hypo/hypernatremic moderate dehydration; laboratory results indicating active colitis e.g. blood , WBC or parasite in stool exam; acute abdomen symptomes or any emergency situation; gastro aesophageal reflux and patient discontinuation and/or premature dismiss.
Age
From 1 year old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences Ethics Committee
Street address
Basij square, Arak University of Medical Sciences, Deputy of Research
City
Arak
Postal code
Approval date
2009-01-20, 1387/11/01
Ethics committee reference number
645 Behsan Software
Health conditions studied
1
Description of health condition studied
acute viral gastroenteritis
ICD-10 code
A08.3
ICD-10 code description
Other viral enteritis
Primary outcomes
1
Description
vomiting
Timepoint
everyday for 4 days
Method of measurement
by nurse
Secondary outcomes
1
Description
extrapyramidal symptomes
Timepoint
everyday for 4 days
Method of measurement
by nurse
Intervention groups
1
Description
addition of Metocloperamid 0.1 mg/kg to serum therapy in case group
Category
Treatment - Drugs
2
Description
standard serum therapy for isonatremic moderate dehydration as described by Nelson textbook of pediatrics in addition to electrolyte correction in control group as below :
maintenance water is calculated as below
for first 10 kg: 100 cc/kg
for second 10 kg: 1000 cc + 50 cc/kg
for over 20 kg: 1500 cc + 20 cc/kg
2400 cc maximum per day
then we multiply that to the degree of dehydration( 5-10%) and so the water deficit is calculated.
first we treat the child with 20 cc/kg of NSS in 20 minutes. total water needed( maintenance+deficit)minus the NSS first treated is the amount to treat with dextrose water 5% plus 20 mEq/L KCl . if ongoing loss happens, for each ml of diarrhea 1 ml of DW5%+ 20 mEq/L NaHCO3 + 20 mEq/L KCl and for each ml of Vomiting 1 ml of NSS+ 10 mEq/L KCl is administered per 1-6 hours as needed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr. Hekmatpoo
Street address
Vice chancellor for research, Arak University of Medical Sciences , Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Frouzifar
Position
Student of Medicine
Other areas of specialty/work
Street address
Student Research committee, Arak University of Medcial Sciences,Arak
City
Arak
Postal code
Phone
+98 86 1417 3502
Fax
Email
src@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medcial Sciences
Full name of responsible person
Parsa Yousefi
Position
Pediatric Nephrology
Other areas of specialty/work
Street address
Dept of Pediatrics, Amirkabir Hospital , Allamolhoda st. Arak