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Описание
Краткое названиеSafety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Полное названиеA Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
СпонсорHelsinn Healthcare SA
Industry
ИсточникHelsinn Healthcare SA
Под контролемUnited States: Food and Drug Administration
Russia: Ethics Committee
Russia: Ministry of Health and Social Development of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
No
Краткое описаниеThe objective of the study is to assess the safety and efficacy of two doses of IV
palonosetron each administered as a single dose for the prevention of postoperative nausea
and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years
inclusive undergoing surgical procedures requiring general endotracheal inhalation
anesthesia.
СостояниеЗавершено
Дата началаAugust 2008
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Набор0
КритерииMAIN INCLUSION CRITERIA

- Male or female patient aged more than 28 days (full term) up to and including 16
years.

- Inpatient scheduled to undergo surgical procedures requiring general endotracheal
anesthesia, including:

- ear, nose and throat surgery;

- eye surgery;

- orchidopexy;

- plastic reconstructive surgery;

- herniorraphy;

- orthopedic surgery).

- American Society of Anesthesiologists (ASA) physical status I, II or III.

- Patient scheduled to receive nitrous oxide during the maintenance phase of
anesthesia.

- Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery

- For female of childbearing potential: the patient and her parent(s)/legal guardian(s)
were counseled on the importance of not becoming pregnant before or during the study
and the patient must have a negative pregnancy test at the pre-treatment visit and at
the study treatment visit.

MAIN EXCLUSION CRITERIA

- For infant aged more than 12 months: a history of gastro-esophageal reflux.

- For patient aged 28 days to 6 years: patient who received any investigational drugs
within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient
who received any investigational drugs within 30 days prior to Day 1.

- Patient scheduled to undergo emergency surgery.

- Patient scheduled to receive regional (spinal) anesthesia in conjunction with general
endotracheal anesthesia.

- Patient scheduled to receive propofol during the maintenance phase of anesthesia.

- Patient with vomiting from any organic cause.

- Any drug with a potential anti-emetic effect within 24 hours prior to the
administration of anesthesia.

- Any vomiting, retching, or nausea in the 24 hours preceding the administration of
anesthesia.
ПолBoth
Минимальный возрастN/A
Максимальный возраст16 Years
УсловиеPostoperative Nausea and Vomiting
Применяемое лечение
Drugpalonosetron
Drugpalonosetron
Контакты и расположение
Cherkassy Cherkassy Regional Hospital, Pediatric Surgery Department
Dnipropetrovsk Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
Donetsk M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
Ivano-Frankivsk Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
Kyiv Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
Kyiv Ukrainian Specialized Children's Hospital "OKHMATDYT", Anesthesiology and Intensive Care Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric Anesthesiology
Kyiv Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
Lviv Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
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