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

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ClinicalTrials.gov Identifier: NCT04060771
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandra Rezende Assad, PhD, Universidade Federal Fluminense

Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE August 19, 2019
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
Vomiting [ Time Frame: 48 hours postoperative ]
Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • Vomiting [ Time Frame: 24 hours postoperative ]
    Quantify the frequency of individual episodes of vomiting at the first 24 hours after surgery.
  • Vomiting [ Time Frame: 6 hours postoperative ]
    Quantify the frequency of individual episodes of vomiting at the first 6 hours after surgery.
  • Vomiting [ Time Frame: 2 hours postoperative ]
    Quantify the frequency of individual episodes of vomiting at the first 2 hours after surgery.
  • Nausea [ Time Frame: 48 hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 48 hours after surgery.
  • Nausea [ Time Frame: 24h hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 24 hours after surgery.
  • Nausea [ Time Frame: 6h hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 6 hours after surgery.
  • Nausea [ Time Frame: 2h hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 2 hours after surgery.
  • Check adverse effects [ Time Frame: 48 hours postoperative ]
    Check the frequency of adverse events (headache, dizziness, drowsiness).
  • Treatment cost [ Time Frame: 48 hours postoperative ]
    Price evaluation of antiemetic drugs.
  • Response to medication [ Time Frame: 48 hours postoperative ]
    Quantify the number of complete responders (individuals who did not have an episode of PONV and did not require rescue medication).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery
Official Title  ICMJE Prospective, Double-blind Study Comparing Palonosetron and Dexamethasone in the Prophylaxis of Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Double (Participant, Investigator)
Masking Description:
Double-blinded
Primary Purpose: Prevention
Condition  ICMJE
  • Anesthesia
  • Strabismus
  • PONV
Intervention  ICMJE
  • Drug: Palonosetron
    prophylaxis of postoperative nausea and vomiting
    Other Name: Prophylactic
  • Drug: Dexamethasone
    prophylaxis of postoperative nausea and vomiting
    Other Name: Prophylactic
Study Arms  ICMJE
  • Experimental: Group P
    During general anesthesia patients will receive a single intravenous dose of palonosetron 1 mcg.Kg-1.
    Intervention: Drug: Palonosetron
  • Active Comparator: Group D
    During general anesthesia patients will receive a single intravenous dose of dexamethasone 0.2 mg.Kg-1.
    Intervention: Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandra R Assad, MD, MSc, PhD 5521999859746 Alexandraassad@hotmail.com
Contact: Ismar L Cavalcanti, MD, MSc, PhD 5521999822993 Ismarcavalcanti@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04060771
Other Study ID Numbers  ICMJE Strabismus surgery
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandra Rezende Assad, PhD, Universidade Federal Fluminense
Study Sponsor  ICMJE Universidade Federal Fluminense
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Júlio CA Moreira, MD Hospital Universitário Antonio Pedro
PRS Account Universidade Federal Fluminense
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP