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

Phase 3

Completed

Interventions: Drug: Palonosetron
Drug: Ondansetron
Drug: Placebo to Ondansetron
Drug: Placebo to Palonosetron

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.

Recruitment & Eligibility

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

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

Locations (43): Shoals Clinical Research Associates
🇺🇸
Florence, Alabama, United States
Shoals Medical Research, LLC
🇺🇸
Sheffield, Alabama, United States
Georgetown University Hospital
🇺🇸
Washington DC, District of Columbia, United States
Bascom Palmer Eye Institute - University of Miami
🇺🇸
Miami, Florida, United States
Louisiana State University Health Sciences Center
🇺🇸
Shreveport, Louisiana, United States
CRC of Jackson
🇺🇸
Jackson, Mississippi, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States
The University of North Carolina Hospitals
🇺🇸
Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Clinical Trial Developers
🇺🇸
Cincinnati, Ohio, United States
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Shoals Clinical Research Associates
🇺🇸Florence, Alabama, United States