Ondansetron LozengeNCT06423820
Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries
A study testing Ondansetron lozenge in people with Ondansetron Lozenge and Postoperative Nausea and Vomiting, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Ondansetron Lozenge, Postoperative Nausea and Vomiting, Pediatrics
- What is being tested?
- Ondansetron lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2024to 23 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 4 to 15 years.
- American Society of Anesthesiology (ASA) physical status I, II.
- Pediatric patients undergoing squint surgeries.
Who cannot join
- Patients who had received any medication with antiemetic properties within 24 h before surgery.
- Post-operative period (for reasons other than rescue antiemetic therapy).
- Patients with known liver or renal disease.
- Patients with a history of vomiting or retching within 24 h before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries: A Randomized Controlled Trial
The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.
Read the detailed description
Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.
In several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.
Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.
- Being tested
- Ondansetron lozenge
- Medical subject headings
- Postoperative Nausea and Vomiting, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron lozengeDrug
Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group S (Ondansetron lozenge) | Experimental | Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group. Receives: Drug: Ondansetron lozenge |
| Group C (Control) | No intervention | Pediatric patients will not receive ondansetron as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
The incidence of postoperative nausea and vomiting (PONV) will be measured in the first 24 postoperative hours at the intervals of 0-2h (early PONV), 2-12h (delayed PONV), and 12- 24h (late PONV)
Measured: 24 hours postoperatively
Secondary outcomes (5)
Severity of postoperative nausea and vomiting (PONV)
The severity of postoperative nausea and vomiting (PONV) will be scored as follows: [0 = no nausea and no retching; 1 complaining of sickness and retching; vomiting one or two times in 30 min; and 3 vomiting more than two times in 30 min] in the first 24 hours postoperatively.
Measured: 24 hours postoperatively
Number of emetic episodes
Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively.
Measured: 24 hours postoperatively
Time to onset of emesis
Time to onset of emesis will be measured from the end of surgery till 24 hours postoperatively.
Measured: 24 hours postoperatively
Incidence of oculo-cardiac reflex (OCR)
Incidence of oculo-cardiac reflex (OCR) will be recorded. OCR is defined as a 10-20% decrease in the resting heart rate and/or the occurrence of any arrhythmia.
Measured: 24 hours postoperatively
Parental satisfaction
Degree of parental satisfaction by using an 11-pointverbal numeric scoring system (0 = not at all satisfied, 10 = fully satisfied).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start21 May 2024
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ondansetron LozengeStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423820
- Sponsor's protocol ID
- 36264PR640/4/24
- Status last verified
- Jan 2025
- First submitted
- 16 May 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Moharam SA, Elsharkawy MS, Zahra SW, Hamama K, Elshikh A, Mahmoud ME, Elsaily AS, Elfatah HF, Shalan FS. Preoperative ondansetron lozenge for prevention of postoperative nausea and vomiting in pediatrics undergoing squint surgeries: a randomized controlled trial. Minerva Anestesiol. 2026 May;92(5):427-434. doi: 10.23736/S0375-9393.26.19496-6. Epub 2026 Feb 5.
PubMed 41642273
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06423820
- Acronym / sponsor ID
- 36264PR640/4/24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 21 May 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 role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.
Detailed description
Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.
In several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.
Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S (Ondansetron lozenge) | Experimental | Drug: Ondansetron lozengePediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group. |
| Group C (Control) | No intervention | –Pediatric patients will not receive ondansetron as a control group. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 4 to 15 years.
- American Society of Anesthesiology (ASA) physical status I, II.
- Pediatric patients undergoing squint surgeries.
Key exclusion criteria (4 listed)
- Patients who had received any medication with antiemetic properties within 24 h before surgery.
- Post-operative period (for reasons other than rescue antiemetic therapy).
- Patients with known liver or renal disease.
- Patients with a history of vomiting or retching within 24 h before surgery.
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 |
|---|---|---|
| Ondansetron lozengePediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. | Drug | Group S (Ondansetron lozenge) |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: 24 hours postoperatively
The incidence of postoperative nausea and vomiting (PONV) will be measured in the first 24 postoperative hours at the intervals of 0-2h (early PONV), 2-12h (delayed PONV), and 12- 24h (late PONV)
5 secondary outcomes
Severity of postoperative nausea and vomiting (PONV)
Time frame: 24 hours postoperatively
Number of emetic episodes
Time frame: 24 hours postoperatively
Time to onset of emesis
Time frame: 24 hours postoperatively
Incidence of oculo-cardiac reflex (OCR)
Time frame: 24 hours postoperatively
Parental satisfaction
Time frame: 24 hours postoperatively
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 30 Jan 2025.
- Derived from this study: PubMed 41642273Moharam SA, Elsharkawy MS, Zahra SW, Hamama K, Elshikh A, Mahmoud ME, Elsaily AS, Elfatah HF, Shalan FS. Preoperative ondansetron lozenge for prevention of postoperative nausea and vomiting in pediatrics undergoing squint surgeries: a randomized controlled trial. Minerva Anestesiol. 2026 May;92(5):427-434. doi: 10.23736/S0375-9393.26.19496-6. Epub 2026 Feb 5.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Ondansetron lozenge in people with Ondansetron Lozenge and Postoperative Nausea and Vomiting, run by Tanta University 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 30 Jan 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. 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?
Incidence of postoperative nausea and vomiting (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423820, which also lists 1 linked publication.
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 30 Jan 2025.