Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative Nausea and Vomiting, palonosetron, pediatric
Brief summary
The 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.
Interventions
DRUGpalonosetron
palonosetron IV 1 mcg/kg
Sponsors
Helsinn Healthcare SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Days to 16 Years
Healthy volunteers
No
Inclusion criteria
MAIN 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively | 0-72 hours post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Complete Response 0-24 Hours | 0-24 hours | Complete Response defined as no vomiting, no retching, and no use of rescue medication |
Countries
Russia, Ukraine
Participant flow
Recruitment details
First patient enrolled: 19 August 2008. Last patient completed: 27 December 2008. A total of 12 Investigators from two countries (Russia and Ukraine) participated in the study. The study was conducted at 4 sites in Russia and 8 sites in Ukraine.
Participants by arm
| Arm | Count |
|---|---|
| 1 mcg/kg Arm Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg | 75 |
| 3 mcg/kg Arm Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Total | 3 mcg/kg Arm | 1 mcg/kg Arm |
|---|---|---|---|
| Age, Customized 12 to <17 years | 47 participants | 22 participants | 25 participants |
| Age, Customized 2 to <6 years | 34 participants | 16 participants | 18 participants |
| Age, Customized <2 years | 7 participants | 4 participants | 3 participants |
| Age, Customized 6 to <12 years | 62 participants | 33 participants | 29 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 150 Participants | 75 Participants | 75 Participants |
| Region of Enrollment Russian Federation | 53 participants | 26 participants | 27 participants |
| Region of Enrollment Ukraine | 97 participants | 49 participants | 48 participants |
| Sex: Female, Male Female | 58 Participants | 29 Participants | 29 Participants |
| Sex: Female, Male Male | 92 Participants | 46 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 74 | 32 / 76 |
| serious Total, serious adverse events | 0 / 74 | 0 / 76 |
Outcome results
Primary
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
Time frame: 0-72 hours post-operatively
Population: The Full Analysis Set (FAS) included all randomized patients, who received the study drug, had general anesthesia and surgery. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the treatment to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 mcg/kg Arm | Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively | 88.0 percentage of patients |
| 3 mcg/kg Arm | Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively | 84.0 percentage of patients |
Secondary
Proportion of Patients With Complete Response 0-24 Hours
Complete Response defined as no vomiting, no retching, and no use of rescue medication
Time frame: 0-24 hours
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 mcg/kg Arm | Proportion of Patients With Complete Response 0-24 Hours | 88.0 percentage of patients |
| 3 mcg/kg Arm | Proportion of Patients With Complete Response 0-24 Hours | 84.0 percentage of patients |