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

A

Aswan University Hospital

Status

Active, not recruiting

Conditions

Postoperative Nausea and Vomiting

Treatments

Other: 10ml normal saline
Drug: famotidine plus10ml normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06211088
Aswu/721/1/23

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 patients

Sex

All

Ages

2 to 13 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

famotidine plus10ml normal saline
Active Comparator group
Description:
Group A:(n. 25) will receive a 5 mg of famotidine that will be diluted to 10ml normal saline in 2 minutes preinduction.
Treatment:
Drug: famotidine plus10ml normal saline
10ml normal saline
Placebo Comparator group
Description:
Group B: Controlled group (n. 25) will receive a10ml normal saline preinduction.
Treatment:
Other: 10ml normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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