Intravenous, Lozenge, Ondansetron, Shivering, Tonsillectomy
Conditions
Brief summary
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.
Interventions
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Patients will receive 4 mg of ondansetron IV just before the surgery.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Age from 4 to 15 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I-II. * Children undergoing tonsillectomy under general anesthesia.
Exclusion criteria
* Allergy to ondansetron. * History of sleep apnea. * Cardiac and respiratory diseases. * Upper respiratory tract infection. * Taking corticosteroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of shivering | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 24 hours postoperatively | Incidence of postoperative nausea and vomiting (PONV) will be recorded. |
| Core temperature | Intraoperatively | Core temperature will be recorded. |
| Peripheral temperature | Intraoperatively | Peripheral temperature will be recorded. |
| Incidence of adverse effects | 24 hours postoperatively | Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded. |
Countries
Egypt
Contacts
CONTACTMohammed S Elsharkawy, MD
Outcome results
None listed