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

NCT06211088 | Completed DMC

• 1 other identifier: Aswu/721/1/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea and Vomiting

Keywords

nausea,vomiting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

famotidine plus10ml normal saline

ACTIVE COMPARATOR

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

Drug: famotidine plus10ml normal saline

10ml normal saline

PLACEBO COMPARATOR

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

Other: 10ml normal saline

Interventions

famotidine plus10ml normal saline DRUG

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

famotidine plus10ml normal saline

10ml normal saline OTHER

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

10ml normal saline

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Zaher

Cairo, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 18, 2024
• Study Start: August 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)