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NCT06211088 Clinical Trial

Famotidine Versus Placebo in Emergency Pediatric Surgery as a Risk to Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06211088
Other study ID # Aswu/721/1/23
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date June 30, 2024

Study information
Verified date January 2024
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

Gastric ultrasound examinations will be performed preoperatively and postoperatively on patients undergoing emergency surgery in pediatric. Gastric cross-sectional area (CSA) will be measured, in order to estimate the gastric volume. The data that will be obtained will be used to evaluate a difference of the gastric volume between the two groups preoperatively and postoperatively and the possible relationship between the gastric volume difference and postoperative adverse event (PONV).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 13 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
Other:
• 10ml normal saline
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by placebo

Locations
Country Name City State
Egypt Zaher Cairo

Sponsors (1)
Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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