OndansetronNCT07489742
Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy
A study testing Ondansetron lozenge and Ondansetron intravenous in people with Ondansetron and Lozenge, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Ondansetron, Lozenge, Intravenous
- What is being tested?
- Ondansetron lozenge and Ondansetron intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Children undergoing tonsillectomy under general anesthesia.
Who cannot join
- Allergy to ondansetron.
- History of sleep apnea.
- Cardiac and respiratory diseases.
- Upper respiratory tract infection.
- Taking corticosteroids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
About this study
Official title: Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy: A Randomized Controlled Trial
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy.
Read the detailed description
Tonsillectomy is one of the most common surgeries in children. The main reason for morbidity in patients undergoing surgical procedures is post-operative complications.
Shivering is random spontaneous and asynchronous skeletal muscle contractions that increases the basal metabolism and is characterized to be a defense mechanism for regulation of temperature.
Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation.
- Conditions
- Ondansetron, Lozenge, Intravenous, Shivering, Tonsillectomy
- Being tested
- Ondansetron lozenge, Ondansetron intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron lozengeDrug
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Ondansetron intravenousDrug
Patients will receive 4 mg of ondansetron IV just before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. Receives: Drug: Ondansetron lozenge |
| Group O | Experimental | Patients will receive 4 mg of ondansetron IV just before the surgery. Receives: Drug: Ondansetron intravenous |
| Group C | No intervention | 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 shivering
Incidence of shivering will be recorded and graded by using the scale validated by Crossley and Mahajan. Crossley and Mahajan grade 0, no shivering; grade 1, no visible muscle activity, but one or more of the following: piloerection, peripheral vasoconstriction, or peripheral cyanosis (other causes excluded); grade 2, muscular activity in only one muscle group; grade 3, moderate muscular activity in more than one muscle group but not generalized shaking; grade 4, violent muscular activity that involves the whole body.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (PONV) will be recorded.
Measured: 24 hours postoperatively
Core temperature
Core temperature will be recorded.
Measured: Intraoperatively
Peripheral temperature
Peripheral temperature will be recorded.
Measured: Intraoperatively
Incidence of adverse effects
Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.
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 posted24 Mar 2026
- Study start25 Mar 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OndansetronStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
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
- NCT07489742
- Sponsor's protocol ID
- 36264PR131011017/2/26
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07489742
- Acronym / sponsor ID
- 36264PR131011017/2/26
- Conditions
- Ondansetron, Lozenge, Intravenous, Shivering, Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Mar 2026 (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.
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy.
Detailed description
Tonsillectomy is one of the most common surgeries in children. The main reason for morbidity in patients undergoing surgical procedures is post-operative complications.
Shivering is random spontaneous and asynchronous skeletal muscle contractions that increases the basal metabolism and is characterized to be a defense mechanism for regulation of temperature.
Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Drug: Ondansetron lozengePatients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
| Group O | Experimental | Drug: Ondansetron intravenousPatients will receive 4 mg of ondansetron IV just before the surgery. |
| Group C | No intervention | –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 (4 listed)
- Age from 4 to 15 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Children undergoing tonsillectomy under general anesthesia.
Key exclusion criteria (5 listed)
- Allergy to ondansetron.
- History of sleep apnea.
- Cardiac and respiratory diseases.
- Upper respiratory tract infection.
- Taking corticosteroids.
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 lozengePatients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. | Drug | Group L |
| Ondansetron intravenousPatients will receive 4 mg of ondansetron IV just before the surgery. | Drug | Group O |
Primary outcome
Incidence of shivering
Time frame: 24 hours postoperatively
Incidence of shivering will be recorded and graded by using the scale validated by Crossley and Mahajan. Crossley and Mahajan grade 0, no shivering; grade 1, no visible muscle activity, but one or more of the following: piloerection, peripheral vasoconstriction, or peripheral cyanosis (other causes excluded); grade 2, muscular activity in only one muscle group; grade 3, moderate muscular activity in more than one muscle group but not generalized shaking; grade 4, violent muscular activity that involves the whole body.
4 secondary outcomes
Incidence of postoperative nausea and vomiting
Time frame: 24 hours postoperatively
Core temperature
Time frame: Intraoperatively
Peripheral temperature
Time frame: Intraoperatively
Incidence of adverse effects
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
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 and Ondansetron intravenous in people with Ondansetron and Lozenge, 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S Elsharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of shivering (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?
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 27 Mar 2026.