Post-Operative Nausea and Vomiting
Conditions
Brief summary
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.
Interventions
DRUGgranisetron
20 micrograms intravenously (iv) 15 min prior to end of surgery
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* males and females 2-16 years of age * scheduled to undergo elective surgery for tonsillectomy or adenotonsillectomy requiring general anesthesia and endotracheal intubation * scheduled for hospital admission for no longer than 24 hours
Exclusion criteria
* known allergy or other contraindication to the use of Kytril or any of its components * known allergy to any other 5HT3 antagonist * history of motion sickness or post-operative nausea or vomiting * nausea or vomiting in the 24 hours prior to anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With no Vomiting | 0-2h after end of surgery (time of extubation) | Number of patients with no vomiting is described as no emesis up to 2 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With no Vomiting | 0-24h after time of extubation | No vomiting describes no emesis during the first 24 hours |
| Time to First Vomiting Episode | 0-24h after time of extubation | Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up. |
| Adverse Experiences | infusion to 15 days post treatment | The adverse events are captured in the AE and SAE section of this database |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Granisetron 20 ug/kg Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery | 70 |
| Granisetron 40 ug/kg Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery | 73 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 3 | 2 |
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Refused Treatment | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Granisetron 20 ug/kg | Granisetron 40 ug/kg | Total |
|---|---|---|---|
| Age, Continuous | 6.0 years STANDARD_DEVIATION 3.37 | 6.2 years STANDARD_DEVIATION 3.12 | 6.1 years STANDARD_DEVIATION 3.24 |
| Sex: Female, Male Female | 22 Participants | 43 Participants | 65 Participants |
| Sex: Female, Male Male | 48 Participants | 30 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 79 | 4 / 78 |
| serious Total, serious adverse events | 6 / 79 | 2 / 78 |
Outcome results
Primary
Number of Patients With no Vomiting
Number of patients with no vomiting is described as no emesis up to 2 hours after surgery
Time frame: 0-2h after end of surgery (time of extubation)
Population: Evaluable Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Granisetron 20 ug/kg | Number of Patients With no Vomiting | 61 participants |
| Granisetron 40 ug/kg | Number of Patients With no Vomiting | 69 participants |
Secondary
Adverse Experiences
The adverse events are captured in the AE and SAE section of this database
Time frame: infusion to 15 days post treatment
Population: Eight of the 157 treated subjects (six and two in the 20- and 40-μg/kg dose groups,respectively) experienced a treatment-emergent serious adverse event up to 15 days after the treatment evaluation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Granisetron 20 ug/kg | Adverse Experiences | 79 Number of participants assessed |
| Granisetron 40 ug/kg | Adverse Experiences | 78 Number of participants assessed |
Secondary
Number of Patients With no Vomiting
No vomiting describes no emesis during the first 24 hours
Time frame: 0-24h after time of extubation
Population: Evaluable Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Granisetron 20 ug/kg | Number of Patients With no Vomiting | 49 participants |
| Granisetron 40 ug/kg | Number of Patients With no Vomiting | 50 participants |
Secondary
Time to First Vomiting Episode
Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up.
Time frame: 0-24h after time of extubation
Population: Evaluable Patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Granisetron 20 ug/kg | Time to First Vomiting Episode | 18.0 hours | Standard Error 1.17 |
| Granisetron 40 ug/kg | Time to First Vomiting Episode | 17.8 hours | Standard Error 1.12 |