Infectious enteritis with vomiting Infections and Infestations Other bacterial intestinal infections
Conditions
Interventions
Treatment with Dimenhydrinate or Placebo in the following dosage:
7-15 kg body weight: 1-2 Supp at 40 mg/24 hours
15-25 kg body weight: 2-3 Supp at 40 mg/24 hours
>25 kg body weight: 2-4 Supp at 40 m
Sponsors
University of Leipzig (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute vomiting started 8-24 hours prior to the inclusion due to suggested infectious enteritis with at least 2 episodes of vomiting in the last 12 hours 2. Age: 6 months-5 years 3. Weight over 7,000 g 4. Outpatients 5. Informed consent of at least one caregiver
Exclusion criteria
Exclusion criteria: 1. Contraindications against the study drug 2. Receipt of the following medications: 2.1. Treatment with medicinal products with suspected interactions with dimenhydrinate 2.2. Treatment with antiemetics or secretion inhibitors 3. Severe disease with one of the following criteria: 3.1. Bloody stool with this disease 3.2. Suggested requirement of intravenous (IV) rehydration 3.3. Confirmed weight loss of more than 7.5% body weight 3.4. Metabolic acidosis (i.e. pH <7.25) and/or electrolyte disturbances (measured by blood test in the emergency clinic originated in the responsibility of the investigator) 4. Suspected lack of cooperation and compliance by the patient or the caregiver(s) or linguistic problems of the parents 5. Participation in other medical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative weight gain from visit 1 to visit 2 (measured as quartile of the weight at visit 1 in stratified rank). Worst rank will be hospitalisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Can the number of vomiting episodes between visit 1 and 2 be reduced by dimenhydrinate versus placebo? 2. Is there a reduction in the number of necessary hospitalisations due to infectious enteritis and vomiting in the study population? 3. Is the condition of the child estimated by their caregivers (measured in a visual scale) improved? 4. Furthermore adverse events and adverse drug reactions will be documented | — |
Countries
Germany
Outcome results
None listed