Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery

Anesthesia Clinical Trial

Official title:

Prospective, Double-blind Study Comparing Palonosetron and Dexamethasone in the Prophylaxis of Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04060771
• Other study ID #: Strabismus surgery
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2019
• Source: Universidade Federal Fluminense
• Contact: Alexandra R Assad, MD, MSc, PhD
• Phone: 5521999859746
• Email: Alexandraassad[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.

Description:

Prospective, double-blind study comparing Palonosetron and Dexamethasone in the prophylaxis of Post-Operative Nausea and Vomiting in children submitted to Strabismus surgery ABSTRACT Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.

Objective: The study aims to compare the incidence of PONV after intravenous administration of palonosetron or dexamethasone in pediatric patients undergoing elective strabismus surgery under general anesthesia.

Materials and Methods: This prospective, double-blind study consist of 80 patients of both genders, classified as ASA grade I and II, ranging in age from 2 to 15 years, scheduled for elective strabismus surgery at Hospital Universitário Antonio Pedro(HUAP), after consent by their parents. Patients will be randomized into two groups of 40 patients each. Group P will receive intravenous dose of palonosetron (1 mg.kg-1), and Group D will receive dexamethasone (0.2 mg.kg-1) after induction of anesthesia. Pacients will be observed for 6 hours before discharge and post-discharge symptoms will be assessed through telephone survey after 24 and 48 hours. At the end of the study, results will be compiled and statistical analysis will be done by using Mann-Whitney test, Chi-squared test and Fisher test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children undergoing elective strabismus surgery

• Physical state according to an American Society of Anesthesiologists (ASA) I and II

Exclusion Criteria:

• Children nor involved in surgery

• Participation in another study in the last month

• Previous history of PONV

• Occurrence of episodes of nausea or vomiting in the last 24 hours before surgery

• Chronic use of corticosteroids

• Previous history of motion sickness

• Use of psychoactive drugs or any other medicine with an antiemetic effect;

• Known hypersensitivity to any study medication

• Severe diseases in organs such as kidney, liver, lung, heart, brain and bone marrow

Related Conditions & MeSH terms

• Anesthesia
• PONV
• Postoperative Nausea and Vomiting
• Strabismus
• Vomiting

Intervention

Drug:
• Palonosetron
prophylaxis of postoperative nausea and vomiting
• Dexamethasone
prophylaxis of postoperative nausea and vomiting

Locations

Country	Name	City	State
Brazil	Hospital Universitário Antonio Pedro	Niterói	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vomiting	Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.	48 hours postoperative
Secondary	Vomiting	Quantify the frequency of individual episodes of vomiting at the first 24 hours after surgery.	24 hours postoperative
Secondary	Vomiting	Quantify the frequency of individual episodes of vomiting at the first 6 hours after surgery.	6 hours postoperative
Secondary	Vomiting	Quantify the frequency of individual episodes of vomiting at the first 2 hours after surgery.	2 hours postoperative
Secondary	Nausea	Quantify the frequency of episodes of nausea at the first 48 hours after surgery.	48 hours postoperative
Secondary	Nausea	Quantify the frequency of episodes of nausea at the first 24 hours after surgery.	24h hours postoperative
Secondary	Nausea	Quantify the frequency of episodes of nausea at the first 6 hours after surgery.	6h hours postoperative
Secondary	Nausea	Quantify the frequency of episodes of nausea at the first 2 hours after surgery.	2h hours postoperative
Secondary	Check adverse effects	Check the frequency of adverse events (headache, dizziness, drowsiness).	48 hours postoperative
Secondary	Treatment cost	Price evaluation of antiemetic drugs.	48 hours postoperative
Secondary	Response to medication	Quantify the number of complete responders (individuals who did not have an episode of PONV and did not require rescue medication).	48 hours postoperative