Postoperative Nausea and VomitingNCT06211088
Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting
A study testing famotidine plus10ml normal saline and 10ml normal saline in people with Postoperative Nausea and Vomiting, run by Aswan University Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 2 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- famotidine plus10ml normal saline and 10ml normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting ꞉ a Comparative Study by Gastric Ultrasound Measurement
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.
Read the detailed 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).
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- famotidine plus10ml normal saline, 10ml normal saline
- Keywords
- nausea,vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
famotidine plus10ml normal salineDrug
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by using 5mg famotidine
10ml normal salineOther
to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: famotidine plus10ml normal saline |
| 10ml normal saline | Placebo comparator | Group B: Controlled group (n. 25) will receive a10ml normal saline preinduction. Receives: Other: 10ml normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaher Zaki Zaher, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211088
- Sponsor's protocol ID
- Aswu/721/1/23
- Status last verified
- Jul 2024
- First submitted
- 26 Dec 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting ꞉ a Comparative Study by Gastric Ultrasound Measurement
- ClinicalTrials.gov ID
- NCT06211088
- Acronym / sponsor ID
- Aswu/721/1/23
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- nausea,vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| famotidine plus10ml normal saline | Active comparator | Drug: famotidine plus10ml normal salineGroup A:(n. 25) will receive a 5 mg of famotidine that will be diluted to 10ml normal saline in 2 minutes preinduction. |
| 10ml normal saline | Placebo comparator | Other: 10ml normal salineGroup B: Controlled group (n. 25) will receive a10ml normal saline preinduction. |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| famotidine plus10ml normal salineto evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by using 5mg famotidine | Drug | famotidine plus10ml normal saline |
| 10ml normal salineto evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by placebo | Other | 10ml normal saline |
Primary outcome
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
Time frame: 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea and Vomiting
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing famotidine plus10ml normal saline and 10ml normal saline in people with Postoperative Nausea and Vomiting, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.