We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395901
First Posted: July 18, 2011
Last Update Posted: July 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helsinn Healthcare SA
  Purpose
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.

Condition Intervention Phase
Postoperative Nausea and Vomiting Drug: Palonosetron Drug: Ondansetron Drug: Placebo to Ondansetron Drug: Placebo to Palonosetron Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.

Resource links provided by NLM:


Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:
  • Proportion of Patients With Complete Response [ Time Frame: 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:
  • Proportion of Patients With no Vomiting [ Time Frame: 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 Emetic Episodes [ Time Frame: 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 Without Antiemetic Rescue Medication [ Time Frame: 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) [ Time Frame: 0-24 hours after T0 ]

Enrollment: 670
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palonosetron and placebo to Ondansetron
Intervention: Drug: Palonosetron
Drug: Palonosetron
Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Drug: Placebo to Ondansetron
Active Comparator: Ondansetron and placebo to Palonosetron
Intervention: Drug: Comparator: Ondansetron
Drug: Ondansetron

Single dose Ondansetron IV:

  • 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
  • 13 years to less than 17 years dose: 4 mg
Drug: Placebo to Palonosetron

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
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): NCT01395901


  Show 44 Study Locations
Sponsors and Collaborators
Helsinn Healthcare SA
  More Information

Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01395901     History of Changes
Other Study ID Numbers: PALO-10-14
First Submitted: July 14, 2011
First Posted: July 18, 2011
Results First Submitted: June 27, 2014
Results First Posted: July 30, 2014
Last Update Posted: July 30, 2014
Last Verified: July 2014

Keywords provided by Helsinn Healthcare SA:
Prevention of Postoperative Nausea and Vomiting
Palonosetron
Ondansetron
Pediatric

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents