Comparison of the effectiveness of therapy bromopride,metoclopramide,e ondasetron Intramuscular for treatment of vomiting

Randomized clinical trial, comparing the effectiveness of therapy bromopride, metoclopramide and ondansetron intramuscular for treatment of vomiting

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-5ky3ks

Enrollment

Unknown

Registered

2015-01-21

Start date

2013-08-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis and non-infectious colitis, unspecified

Interventions

All children who arrive at the emergency department with vomiting Pediatric ready for suspected gastroenteritis (intestinal infection), will be randomly selected to receive medication to stop the vomi

Group 2:60 children, intramuscular injection of metoclopramide (0.15 mg / kg / dose

Group 3:60 children, intramuscular injection of ondansetron (0.15 mg / kg / dose. every child will be under observation for an hour. Thirty minutes after receiving medication, will be offered 200 ml o

Drug

D27.505.954.483.200 -Antieméticos

Eligibility

Age

1 Years to 12 Years

Inclusion criteria

Inclusion criteria: children who have experienced two or more episodes of vomiting in the last 24 hours, aged 1 year to 12 years, both genders; medical indication for receiving intramuscular antiemetic; when the country or guardians agree with the inclusion of a dependent in the study

Exclusion criteria

Exclusion criteria: bromopride known allergy to metoclopramide and ondansetron; vomiting due to sedation, anesthesia or chemotherapy; teenagers pregnant and / or breastfeeding; heart disease, advanced renal disease, urinary tract infection, epilepsy, intestinal obstruction, appendicitis, meningitis and diabetes mellitus, malnutrition, pneumonia, brain tumor

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of bromopride, metoclopramide and ondansetron in a single intramuscular dose for treatment of vomiting in children treated in an emergency pediátrica. Comparando the vomiting termination rates verified by measuring the observation of the researcher and parents' reports from the observation one significant variation among the three drugs tested in the reduction of vomiting after use.;Assess the number of late adverse events after use of antiemetics, observed by family members in the household in 24 hours and recorded by the researchers. To evaluate the oral acceptance of fluids after use of antiemetics and the comparison between the three drugs. Recorded and observed by researchers.	—

Measure

Time frame

To evaluate the efficacy of bromopride, metoclopramide and ondansetron in a single intramuscular dose for treatment of vomiting in children treated in an emergency pediátrica. Comparando the vomiting termination rates verified by measuring the observation of the researcher and parents' reports from the observation one significant variation among the three drugs tested in the reduction of vomiting after use.;Assess the number of late adverse events after use of antiemetics, observed by family members in the household in 24 hours and recorded by the researchers. To evaluate the oral acceptance of fluids after use of antiemetics and the comparison between the three drugs. Recorded and observed by researchers.

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Secondary

Measure	Time frame
Within 24 hours, the cessation of vomiting occurred in 67.8% with bromopride, 67.2% with metoclopramide and 96.6% with ondansetron (p = 0.002). ;We compared the episodes of diarrhea before medicating (p = 0.039) and after doctoring (p = 0.183) for evaluating whether the drugs caused an increase of diarrhea. It was found that there was no increase in diarrhea, however, children decreased the number of evacuations after medicating.;Ondansetron group accepted best oral liquids, 200 ml, compared to bromopride, 150 ml and metoclopramide, 100 ml (p = 0.034).; Ondansetron was effective in the first hour and also in the next 6 h. No known side effects, had better success of oral rehydration, intravenous hydration and avoided hospitalization. The bromopride and metoclopramide were considered effective, but cause drowsiness which can increase the time of observation and hospital costs.	—

Measure

Time frame

Within 24 hours, the cessation of vomiting occurred in 67.8% with bromopride, 67.2% with metoclopramide and 96.6% with ondansetron (p = 0.002). ;We compared the episodes of diarrhea before medicating (p = 0.039) and after doctoring (p = 0.183) for evaluating whether the drugs caused an increase of diarrhea. It was found that there was no increase in diarrhea, however, children decreased the number of evacuations after medicating.;Ondansetron group accepted best oral liquids, 200 ml, compared to bromopride, 150 ml and metoclopramide, 100 ml (p = 0.034).; Ondansetron was effective in the first hour and also in the next 6 h. No known side effects, had better success of oral rehydration, intravenous hydration and avoided hospitalization. The bromopride and metoclopramide were considered effective, but cause drowsiness which can increase the time of observation and hospital costs.

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Countries

Brazil

Contacts

Public ContactMatias;Rita Epifanio;Mattiello

Pontificia Universidade Católoica do Rio Grande do Sul;Pontificia Universidade Católoica do Rio Grande do Sul

mepifanio@hotmail.com;rita.mattiello@pucrs.br+55 (51) 9999 6248;+55 (51) 9327 3252

Outcome results

None listed

Source: REBEC (via WHO ICTRP)