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

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

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.

Study Overview

• Status: Unknown
• Conditions: Strabismus; Anesthesia; PONV
• Intervention / Treatment: Drug: Palonosetron; Drug: Dexamethasone

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexandra R Assad, MD, MSc, PhD; Phone Number: 5521999859746; Email: Alexandraassad@hotmail.com
• Study Contact Backup: Name: Ismar L Cavalcanti, MD, MSc, PhD; Phone Number: 5521999822993; Email: Ismarcavalcanti@gmail.com

Study Locations

• Brazil
  • Rio De Janeiro
    • Niterói, Rio De Janeiro, Brazil, 24033900
      • Recruiting
      • Hospital Universitario Antonio Pedro
      • Principal Investigator: Júlio CA Moreira, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group P; During general anesthesia patients will receive a single intravenous dose of palonosetron 1 mcg.Kg-1.	Drug: Palonosetron; prophylaxis of postoperative nausea and vomiting; Other Names: Prophylactic
Active Comparator: Group D; During general anesthesia patients will receive a single intravenous dose of dexamethasone 0.2 mg.Kg-1.	Drug: Dexamethasone; prophylaxis of postoperative nausea and vomiting; Other Names: Prophylactic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vomiting	Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.	48 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vomiting	Quantify the frequency of individual episodes of vomiting at the first 24 hours after surgery.	24 hours postoperative
Vomiting	Quantify the frequency of individual episodes of vomiting at the first 6 hours after surgery.	6 hours postoperative
Vomiting	Quantify the frequency of individual episodes of vomiting at the first 2 hours after surgery.	2 hours postoperative
Nausea	Quantify the frequency of episodes of nausea at the first 48 hours after surgery.	48 hours postoperative
Nausea	Quantify the frequency of episodes of nausea at the first 24 hours after surgery.	24h hours postoperative
Nausea	Quantify the frequency of episodes of nausea at the first 6 hours after surgery.	6h hours postoperative
Nausea	Quantify the frequency of episodes of nausea at the first 2 hours after surgery.	2h hours postoperative
Check adverse effects	Check the frequency of adverse events (headache, dizziness, drowsiness).	48 hours postoperative
Treatment cost	Price evaluation of antiemetic drugs.	48 hours postoperative
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

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: Júlio CA Moreira, MD, Hospital Universitario Antonio Pedro

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Anesthesia; Strabismus; PONV
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Postoperative Complications; Signs and Symptoms, Digestive; Cranial Nerve Diseases; Ocular Motility Disorders; Nausea; Vomiting; Strabismus; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Dexamethasone; Palonosetron
• Other Study ID Numbers: Strabismus surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No