Actively Recruiting
Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy: A Randomized Controlled Trial
Led by Tanta University · Updated on 2026-03-27
210
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the prevention of shivering in children aged 4 to 15 years undergoing tonsillectomy, a common surgery in this age group. Shivering is a spontaneous muscle activity that can increase metabolism and cause discomfort after surgery. The study compares two methods of administering ondansetron, a drug known to block certain receptors and used to prevent shivering during and after operations. Participants will be randomly assigned to one of three groups: one group will receive a 4 mg ondansetron lozenge two hours before surgery, another group will receive a 4 mg intravenous dose just before surgery, and a control group will not receive ondansetron. The study aims to evaluate the effect of these different administration routes on shivering prevention. During the study, researchers will monitor the incidence of shivering within 24 hours after surgery, as well as other outcomes like postoperative nausea and vomiting, body temperature during surgery, and any adverse effects. The trial will follow participants through the surgery and the first 24 hours postoperatively to assess these outcomes and safety.
CONDITIONS
Brief Title
Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 4 to 15 years
- Both sexes
- American Society of Anesthesiology (ASA) physical status I-II
- Children undergoing tonsillectomy under general anesthesia
You will not qualify if you...
- Allergy to ondansetron
- History of sleep apnea
- Cardiac and respiratory diseases
- Upper respiratory tract infection
- Taking corticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants receive ondansetron either as a lozenge 2 hours before surgery or intravenously just before surgery, or no ondansetron if in the control group, during tonsillectomy.
1 visit (in-person) for administration and surgery
Duration - 24 hours postoperatively
Participants are monitored for shivering, nausea, vomiting, temperature, and adverse effects for 24 hours after surgery.
1 follow-up visit or monitoring period
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
M
Mohammed S Elsharkawy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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