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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00231478
• Collaborator: (none)
• Enrollment: 171
• Locations: 11
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 15.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Nausea and Vomiting	Drug: granisetron; Drug: granisetron	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind Study of 2 Dose Levels of Kytril on the Prevention of Post-operative Nausea and Vomiting in Pediatric Patients Undergoing Surgery With General Anesthesia
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: granisetron; 20 micrograms intravenously (iv) 15 min prior to end of surgery; Other Names: Kytril
Experimental: 2	Drug: granisetron; 40 micrograms intravenously (iv) 15 min prior to end of surgery; Other Names: Kytril

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Number of Patients With no Vomiting [0-24h after time of extubation]

   No vomiting describes no emesis during the first 24 hours

2. 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.

3. Adverse Experiences [infusion to 15 days post treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fresno	California	United States	93720
2		Stanford	California	United States	94305-5118
3		Hartford	Connecticut	United States	06106
4		Miami	Florida	United States	33136
5		Atlanta	Georgia	United States	30322
6		Indianapolis	Indiana	United States	46223
7		Baltimore	Maryland	United States	21287
8		Boston	Massachusetts	United States	02114
9		Pittsburgh	Pennsylvania	United States	15213
10		Nashville	Tennessee	United States	37232
11		Dallas	Texas	United States	75235

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00231478
• Other Study ID Numbers: ML16633
• First Posted: Oct 4, 2005
• Last Update Posted: Mar 27, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Granisetron

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Granisetron 20 ug/kg	Granisetron 40 ug/kg	Total
Arm/Group Description	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery	Total of all reporting groups
Overall Participants	70	73	143
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	6.0 (3.37)	6.2 (3.12)	6.1 (3.24)
Sex: Female, Male (Count of Participants)
Female	22 31.4%	43 58.9%	65 45.5%
Male	48 68.6%	30 41.1%	78 54.5%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With no Vomiting
Description	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)

Outcome Measure Data

Analysis Population Description

Evaluable Patients

Arm/Group Title	Granisetron 20 ug/kg	Granisetron 40 ug/kg
Arm/Group Description	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Measure Participants	70	73
Number [participants]	61 87.1%	69 94.5%

2. Secondary Outcome

Title	Number of Patients With no Vomiting
Description	No vomiting describes no emesis during the first 24 hours
Time Frame	0-24h after time of extubation

Outcome Measure Data

Analysis Population Description

Evaluable Patients

Arm/Group Title	Granisetron 20 ug/kg	Granisetron 40 ug/kg
Arm/Group Description	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Measure Participants	70	73
Number [participants]	49 70%	50 68.5%

3. Secondary Outcome

Title	Time to First Vomiting Episode
Description	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

Outcome Measure Data

Analysis Population Description

Evaluable Patients

Arm/Group Title	Granisetron 20 ug/kg	Granisetron 40 ug/kg
Arm/Group Description	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Measure Participants	70	73
Mean (Standard Error) [hours]	18.0 (1.17)	17.8 (1.12)

4. Secondary Outcome

Title	Adverse Experiences
Description	The adverse events are captured in the AE and SAE section of this database
Time Frame	infusion to 15 days post treatment

Outcome Measure Data

Analysis Population Description

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/Group Title	Granisetron 20 ug/kg	Granisetron 40 ug/kg
Arm/Group Description	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery	Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
Measure Participants	79	78
Number [Number of participants assessed]	79 112.9%	78 106.8%

Adverse Events

Time Frame	Infusion to 15 days post treatment
Adverse Event Reporting Description	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/Group Title	Granisetron 20 ug/kg		Granisetron 40 ug/kg
Arm/Group Description	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery		Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
All Cause Mortality
	Granisetron 20 ug/kg		Granisetron 40 ug/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Granisetron 20 ug/kg		Granisetron 40 ug/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/79 (7.6%)		2/78 (2.6%)
General disorders
dehydration	2/79 (2.5%)		0/78 (0%)
oral intake reduced	1/79 (1.3%)		1/78 (1.3%)
Metabolism and nutrition disorders
oxygen saturation reduced	0/79 (0%)		1/78 (1.3%)
Surgical and medical procedures
post procedural haemorrhage	2/79 (2.5%)		1/78 (1.3%)
procedural pain	0/79 (0%)		1/78 (1.3%)
Vascular disorders
migraine	1/79 (1.3%)		0/78 (0%)
Other (Not Including Serious) Adverse Events
	Granisetron 20 ug/kg		Granisetron 40 ug/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/79 (7.6%)		4/78 (5.1%)
Gastrointestinal disorders
vomiting	6/79 (7.6%)		4/78 (5.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

"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."