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

NCT ID: NCT06211088

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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famotidine plus10ml normal saline

Group A:(n. 25) will receive a 5 mg of famotidine that will be diluted to 10ml normal saline in 2 minutes preinduction.

Group Type ACTIVE_COMPARATOR

famotidine plus10ml normal saline

Intervention Type DRUG

to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by using 5mg famotidine

10ml normal saline

Group B: Controlled group (n. 25) will receive a10ml normal saline preinduction.

Group Type PLACEBO_COMPARATOR

10ml normal saline

Intervention Type OTHER

to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by placebo

Interventions

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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

Intervention Type DRUG

10ml normal saline

to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zaher Zaki Zaher

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zaher

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Aswu/721/1/23

Identifier Type: -

Identifier Source: org_study_id

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