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Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

ConditionsOndansetronLozengeIntravenousShiveringTonsillectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-15
SponsorTanta University

About this trial

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 4 to 15 years.

Both sexes.

American Society of Anesthesiology (ASA) physical status I-II.

Children undergoing tonsillectomy under general anesthesia.

Disqualifiers

Allergy to ondansetron.

History of sleep apnea.

Cardiac and respiratory diseases.

Upper respiratory tract infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ondansetron lozenge

    Drug

    Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

  • Ondansetron intravenous

    Drug

    Patients will receive 4 mg of ondansetron IV just before the surgery.

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Group LExperimental treatment 1 intervention
Group B: Group OExperimental treatment 1 intervention
Group C: Group CNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours postoperatively

Secondary outcomes

1

Incidence of postoperative nausea and vomiting

Incidence of postoperative nausea and vomiting (PONV) will be recorded.

Time frame
24 hours postoperatively
2

Core temperature

Core temperature will be recorded.

Time frame
Intraoperatively
3

Peripheral temperature

Peripheral temperature will be recorded.

Time frame
Intraoperatively
4

Incidence of adverse effects

Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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