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Effects of dimenhydrinate in children with acute gastroenteritis

Study of effect of oral dimenhydrinate in children with acute gastroenteritis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014083018974N1
Enrollment
200
Registered
2015-03-02
Start date
2014-12-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

acute gastroenteritis. Noninfective gastroenteritis and colitis, unspecified

Interventions

Intervention 1: Dimenhydrinate 4 doses (1mg/kg dose max 200 mg/dose). Intervention 2: placebo doses (1 mg / kg / dose to 50 mg / dose) during 6 days per week.
Treatment - Drugs
Placebo
Dimenhydrinate 4 doses (1mg/kg dose max 200 mg/dose)
placebo doses (1 mg / kg / dose to 50 mg / dose) during 6 days per week

Sponsors

Vice chancellor for research, Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Diagnosis of acute gastroenteritis by Specialist Physicians, At least 5 episodes of vomiting in 12 Hours; Aged between 1 to 12 years. Exclusion criteria: Chronic medical conditions of pre-existing such as gastrointestinal disease; malignancy; metabolic; cardiac; endocrine and metabolism, immune or nervous disorder. Secondary diagnosis of suspected from abdominal surgery or Or gynecologic conditions, urinary tract infections; migraine or meningitis. The use of antiemetic therapy in the 48 hours before the visit to the emergency. Use of other drugs such as acetaminophen or ibuprofen in the last 48 hours. History of allergies or adverse reactions to dimenhydrinate. Severe loss of water and requires urgent treatment with intravenous fluids. Hematemesis or hematochezia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The number of vomiting episodes. Timepoint: Within 24 hours after using the first dose of prescription medication. Method of measurement: visit.

Secondary

MeasureTime frame
The number of episodes of diarrhea. Timepoint: Within 24 hours after using the first dose of prescription medication. Method of measurement: visit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Akramipour

Kermanshah university of medical sciences

Akramipur20@yahoo.com+98 83 3721 8202

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026