Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

Phase 3

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Palonosetron; Drug: Ondansetron; Drug: Placebo to Ondansetron; Drug: Placebo to Palonosetron

• Registration Number: NCT01395901
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Disposition First Submitted: 2013-03-28
• Disposition First Submitted QC: 2013-03-28
• Disposition First Posted: 2013-04-04
• Results First Submitted: 2014-06-27
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-29
• Last Update Submitted: 2014-07-29
• Results First Posted: 2014-07-30
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

• Male or female patient aged from full term neonate to less than 17 years.

• In-patient or out-patient scheduled to undergo one of the following procedures:

  • ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy),
  • eye surgery (e.g. strabismus, vitreoretinal, cataract surgery),
  • urological surgery (e.g. orchidopexy, varicocoele),
  • plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp),
  • hernia repair,
  • orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery),.
  • cardiac surgery,
  • neurosurgery.

• Patient is scheduled to undergo surgery requiring general intravenous anesthesia

• Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia

• Patient weighs at least 3.2 kg

• ASA physical status I, II or III

• Fertile patients (male or female) must use reliable contraceptive measures

• Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2)

• For patients with known hepatic impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study

• For patients with known renal impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study

Read More

Exclusion Criteria

• Lactating females
• Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
• Patient having participated in any previous trial with palonosetron.
• History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists
• Patient to undergo emergency surgery
• Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia
• Patient scheduled to receive laryngeal mask anesthesia
• Patient scheduled to receive propofol during the maintenance phase of anesthesia
• Patient suffering from any concomitant disease uncontrolled by therapy, which, in the judgment of the Investigator, could compromise the outcome of surgery
• Patient with history of gastro-esophageal reflux (except for patients up to 12 months)
• Patient with ongoing vomiting from any organic cause
• Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palonosetron and placebo to Ondansetron	Placebo to Ondansetron	Intervention: Drug: Palonosetron
Palonosetron and placebo to Ondansetron	Palonosetron	Intervention: Drug: Palonosetron
Ondansetron and placebo to Palonosetron	Placebo to Palonosetron	Intervention: Drug: Comparator: Ondansetron
Ondansetron and placebo to Palonosetron	Ondansetron	Intervention: Drug: Comparator: Ondansetron

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Complete Response	0-24 hours after T0	Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Without Emetic Episodes	0-24 hours after T0	An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Proportion of Patients With no Vomiting	0-24 hours after T0	Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Proportion of Patients Without Antiemetic Rescue Medication	0-24 hours after T0	Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Proportion of Patients Without Nausea (Patient Aged > 6 Years)	0-24 hours after T0

Trial Locations

Locations (43)

Louisiana State University Health Sciences Center; 🇺🇸 Shreveport, Louisiana, United States

Department of Intensive Care and Anesthesiology; 🇵🇱 Olsztyn, Poland

Shoals Medical Research, LLC; 🇺🇸 Sheffield, Alabama, United States

Shoals Clinical Research Associates; 🇺🇸 Florence, Alabama, United States

CRC of Jackson; 🇺🇸 Jackson, Mississippi, United States

Bascom Palmer Eye Institute - University of Miami; 🇺🇸 Miami, Florida, United States

Clinical Trial Developers; 🇺🇸 Cincinnati, Ohio, United States

Texas Orthopedic Specialist, P.A; 🇺🇸 Grapevine, Texas, United States

The University of North Carolina Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University Hospital Olomouc; 🇨🇿 Olomouc, Czech Republic

University Hospital Pilsen- Paediatric Clinic; 🇨🇿 Plzen-Lochotin, Czech Republic

University Hospital Motol; 🇨🇿 Praha, Czech Republic

The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit; 🇭🇺 Budapest, Hungary

St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit; 🇭🇺 Dunaújváros, Hungary

St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit; 🇭🇺 Budapest, Hungary

Department of Pediatric Surgery and Urology of Medical University of Gdansk; 🇵🇱 Gdansk, Poland

Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit; 🇭🇺 Gyula, Hungary

Department of Pediatric Anesthesiology and Intensive Care; 🇵🇱 Lublin, Poland

Department of Pediatric Surgery; 🇵🇱 Wroclaw, Poland

University Pediatric Hospital; 🇵🇷 San Juan, Puerto Rico

State Healthcare Institution Arkhangelsk Regional Children's Hospital; 🇷🇺 Arkhangelsk, Russian Federation

Federal State Institution: St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the MoH Care and Social Development of the Russian Federation; 🇷🇺 Saint Petersburg, Russian Federation

International Clinic MEDEM; 🇷🇺 Saint Petersburg, Russian Federation

Yaroslavl Region State Healthcare Institution; 🇷🇺 Yaroslavl, Russian Federation

St. Petersburg State Pediatric Medical Academy; 🇷🇺 St-Petersburg, Russian Federation

Dnipropetrovsk Regional Childrens Clinical Hospital; 🇺🇦 Dnipropetrovsk, Ukraine

Regional Childrens Clinical Hospital; 🇺🇦 Donetsk, Ukraine

Ivano-Frankivsk Regional Childrens Clinical Hospital; 🇺🇦 Ivano-Frankivsk, Ukraine

City Clinical Hospital n#30; 🇺🇦 Kharkiv, Ukraine

V.P. Filatov Institute of Eye Diseases and Tissue Therapy; 🇺🇦 Odesa, Ukraine

Zaporizhia Regional Clinical Childrens Hospital; 🇺🇦 Zaporizhia, Ukraine

National Specialized Childrens Hospital OKHMATDYT; 🇺🇦 Kyiv, Ukraine

Semmeleis University; 🇭🇺 Budapest, Hungary

CEMIC, Otorhinolaryngology Department; 🇦🇷 Buenos Aires, Argentina

University Hospital Brno - Children's Medical Centre; 🇨🇿 Brno, Czech Republic

Georgetown University Hospital; 🇺🇸 Washington DC, District of Columbia, United States

Hospital Znojmo, State-Funded Organisation, Department of Pediatrics; 🇨🇿 Znojmo, Czech Republic

Research and Development Center for Prophylactic and Clinical Medicine; 🇺🇦 Kyiv, Ukraine

Istituto Medico Rio Cuarto; 🇦🇷 Rio Cuarto, Argentina

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czech Republic

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States