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

NCT04060771 | Unknown Phase 3

• 1 other identifier: Strabismus surgery
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Strabismus; PONV

Keywords

Anesthesia; Strabismus; PONV

Outcome Measures

Primary Outcomes (1)

• Vomiting

  Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.

  48 hours postoperative

Secondary Outcomes (10)

• Vomiting

  24 hours postoperative

• Vomiting

  6 hours postoperative

• Vomiting

  2 hours postoperative

• Nausea

  48 hours postoperative

• Nausea

  24h hours postoperative

Study Arms (2)

Group P

EXPERIMENTAL

During general anesthesia patients will receive a single intravenous dose of palonosetron 1 mcg.Kg-1.

Drug: Palonosetron

Group D

ACTIVE COMPARATOR

During general anesthesia patients will receive a single intravenous dose of dexamethasone 0.2 mg.Kg-1.

Drug: Dexamethasone

Interventions

Palonosetron DRUG

prophylaxis of postoperative nausea and vomiting

Also known as: Prophylactic

Group P

Dexamethasone DRUG

prophylaxis of postoperative nausea and vomiting

Also known as: Prophylactic

Group D

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children undergoing elective strabismus surgery
• Physical state according to an American Society of Anesthesiologists (ASA) I and II

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Hospital Universitário Antonio Pedro

Niterói, Rio de Janeiro, 24033900, Brazil

RECRUITING

MeSH Terms

Conditions

Strabismus; Postoperative Nausea and Vomiting

Interventions

Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Júlio CA Moreira, MD

  Hospital Universitário Antonio Pedro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra R Assad, MD, MSc, PhD

CONTACT

5521999859746; Alexandraassad@hotmail.com

Ismar L Cavalcanti, MD, MSc, PhD

CONTACT

5521999822993; Ismarcavalcanti@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be divided between two groups, Group P will receive single dose of palonosetron whereas Group D will receive a single dose of dexamethasone during general anesthesia.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: August 19, 2019
• Study Start: August 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2020
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

BR (1)