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Clinical trial

Famotidine Versus Placebo in Emergency Pediatric Surgery as a Risk to Postoperative Nausea and Vomiting ꞉ A Comparative Study by Gastric Ultrasound Measurement

ID
Name
Aswu/721/1/23
Description
The aim of this study is to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of PONV.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-01-30
Trial end
2024-06-30
Status
Active (not recruiting)
Treatment
famotidine plus10ml normal saline
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by using 5mg famotidine
Arms:
famotidine plus10ml normal saline
10ml normal saline
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by placebo
Arms:
10ml normal saline
Size
50
Primary endpoint
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum by gastric ultrasound preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of postoperative nausea and vomiting
12 months
Eligibility criteria
Inclusion Criteria: * Pediatrics patients aging between 2-13 years . * pediatrics undergo urgent surgery (i.e., surgery that cannot be postponed for more than 48 h since clinical onset). * PatientPediatrics come in trauma Exclusion Criteria: * PatientPediatrics severly shocked . * PatientPediatrics with diffusely distended abdomen as this will obstacle gastric ultrasound . * PatientPediatrics with history of hypersenstivity to famotidine . * PatientPediatrics with hepatic or renal impairments
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-01-18

1 organization

1 product

1 indication

Organization
Aswan University Hospital
Product
Famotidine
Indication
Postoperative Nausea and Vomiting