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This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
|
| Group O | Experimental | Patients will receive 4 mg of ondansetron IV just before the surgery. |
|
| Group C | No Intervention | Patients will not receive ondansetron as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron lozenge | Drug | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (PONV) will be recorded. | 24 hours postoperatively |
| Core temperature | Core temperature will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed S Elsharkawy, MD | Contact | 00201148207870 | mselsharkawy@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Ondansetron intravenous | Drug | Patients will receive 4 mg of ondansetron IV just before the surgery. |
|
| Intraoperatively |
| Peripheral temperature | Peripheral temperature will be recorded. | Intraoperatively |
| Incidence of adverse effects | Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded. | 24 hours postoperatively |