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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

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.

Condition or disease Intervention/treatment Phase
Anesthesia Strabismus PONV Drug: Palonosetron Drug: Dexamethasone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Prophylactic




Primary Outcome Measures :
  1. Vomiting [ Time Frame: 48 hours postoperative ]
    Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.


Secondary Outcome Measures :
  1. Vomiting [ Time Frame: 24 hours postoperative ]
    Quantify the frequency of individual episodes of vomiting at the first 24 hours after surgery.

  2. Vomiting [ Time Frame: 6 hours postoperative ]
    Quantify the frequency of individual episodes of vomiting at the first 6 hours after surgery.

  3. Vomiting [ Time Frame: 2 hours postoperative ]
    Quantify the frequency of individual episodes of vomiting at the first 2 hours after surgery.

  4. Nausea [ Time Frame: 48 hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 48 hours after surgery.

  5. Nausea [ Time Frame: 24h hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 24 hours after surgery.

  6. Nausea [ Time Frame: 6h hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 6 hours after surgery.

  7. Nausea [ Time Frame: 2h hours postoperative ]
    Quantify the frequency of episodes of nausea at the first 2 hours after surgery.

  8. Check adverse effects [ Time Frame: 48 hours postoperative ]
    Check the frequency of adverse events (headache, dizziness, drowsiness).

  9. Treatment cost [ Time Frame: 48 hours postoperative ]
    Price evaluation of antiemetic drugs.

  10. 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).



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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060771


Contacts
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Contact: Alexandra R Assad, MD, MSc, PhD 5521999859746 Alexandraassad@hotmail.com
Contact: Ismar L Cavalcanti, MD, MSc, PhD 5521999822993 Ismarcavalcanti@gmail.com

Locations
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Brazil
Hospital Universitário Antonio Pedro Recruiting
Niterói, Rio De Janeiro, Brazil, 24033900
Principal Investigator: Júlio CA Moreira, Md         
Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
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Principal Investigator: Júlio CA Moreira, MD Hospital Universitário Antonio Pedro
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Responsible Party: Alexandra Rezende Assad, PhD, Professor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT04060771    
Other Study ID Numbers: Strabismus surgery
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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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
Keywords provided by Alexandra Rezende Assad, PhD, Universidade Federal Fluminense:
Anesthesia
Strabismus
PONV
Additional relevant MeSH terms:
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Strabismus
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
Dexamethasone
Palonosetron
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action