Trial Outcomes & Findings for A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy (NCT NCT00231478)

NCT ID: NCT00231478

Last Updated: 2018-03-27

Results Overview

Number of patients with no vomiting is described as no emesis up to 2 hours after surgery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 171 participants
• Primary outcome timeframe: 0-2h after end of surgery (time of extubation)
• Results posted on: 2018-03-27

Participant Flow

Participant milestones

Measure	Granisetron 20 ug/kg Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Overall Study STARTED	87	84
Overall Study COMPLETED	79	78
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	Granisetron 20 ug/kg Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Overall Study Protocol Violation	3	2
Overall Study Refused Treatment	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse Event	0	1
Overall Study Administrative	3	2

Baseline Characteristics

A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy

Baseline characteristics by cohort

Measure	Granisetron 20 ug/kg n=70 Participants Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg n=73 Participants Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery	Total n=143 Participants Total of all reporting groups
Age, Continuous	6.0 years STANDARD_DEVIATION 3.37 • n=93 Participants	6.2 years STANDARD_DEVIATION 3.12 • n=4 Participants	6.1 years STANDARD_DEVIATION 3.24 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	43 Participants n=4 Participants	65 Participants n=27 Participants
Sex: Female, Male Male	48 Participants n=93 Participants	30 Participants n=4 Participants	78 Participants n=27 Participants

PRIMARY outcome

Timeframe: 0-2h after end of surgery (time of extubation)

Population: Evaluable Patients

Number of patients with no vomiting is described as no emesis up to 2 hours after surgery

Outcome measures

Measure	Granisetron 20 ug/kg n=70 Participants Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg n=73 Participants Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Number of Patients With no Vomiting	61 participants	69 participants

SECONDARY outcome

Timeframe: 0-24h after time of extubation

Population: Evaluable Patients

No vomiting describes no emesis during the first 24 hours

Outcome measures

Measure	Granisetron 20 ug/kg n=70 Participants Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg n=73 Participants Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Number of Patients With no Vomiting	49 participants	50 participants

SECONDARY outcome

Timeframe: 0-24h after time of extubation

Population: Evaluable Patients

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.

Outcome measures

Measure	Granisetron 20 ug/kg n=70 Participants Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg n=73 Participants Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Time to First Vomiting Episode	18.0 hours Standard Error 1.17	17.8 hours Standard Error 1.12

SECONDARY outcome

Timeframe: 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.

The adverse events are captured in the AE and SAE section of this database

Outcome measures

Measure	Granisetron 20 ug/kg n=79 Participants Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg n=78 Participants Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Adverse Experiences	79 Number of participants assessed	78 Number of participants assessed

Adverse Events

Granisetron 20 ug/kg

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Granisetron 40 ug/kg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Granisetron 20 ug/kg n=79 participants at risk Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg n=78 participants at risk Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
General disorders dehydration	2.5% 2/79 • Infusion to 15 days post treatment 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.	0.00% 0/78 • Infusion to 15 days post treatment 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.
Vascular disorders migraine	1.3% 1/79 • Infusion to 15 days post treatment 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.	0.00% 0/78 • Infusion to 15 days post treatment 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.
General disorders oral intake reduced	1.3% 1/79 • Infusion to 15 days post treatment 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.	1.3% 1/78 • Infusion to 15 days post treatment 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.
Surgical and medical procedures post procedural haemorrhage	2.5% 2/79 • Infusion to 15 days post treatment 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.	1.3% 1/78 • Infusion to 15 days post treatment 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.
Metabolism and nutrition disorders oxygen saturation reduced	0.00% 0/79 • Infusion to 15 days post treatment 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.	1.3% 1/78 • Infusion to 15 days post treatment 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.
Surgical and medical procedures procedural pain	0.00% 0/79 • Infusion to 15 days post treatment 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.	1.3% 1/78 • Infusion to 15 days post treatment 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.

Other adverse events

Measure	Granisetron 20 ug/kg n=79 participants at risk Drug: granisetron \[Kytril\], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Granisetron 40 ug/kg n=78 participants at risk Drug: granisetron \[Kytril\] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Gastrointestinal disorders vomiting	7.6% 6/79 • Infusion to 15 days post treatment 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.	5.1% 4/78 • Infusion to 15 days post treatment 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.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Results disclosure agreements

• Principal investigator is a sponsor employee "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."
• Publication restrictions are in place

Restriction type: OTHER