NCT00231478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 28, 2011

Completed
Last Updated

March 27, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

September 30, 2005

Results QC Date

March 30, 2011

Last Update Submit

February 26, 2018

Conditions

Post-Operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With no Vomiting

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

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

Secondary Outcomes (3)

  • Number of Patients With no Vomiting

    0-24h after time of extubation

  • Time to First Vomiting Episode

    0-24h after time of extubation

  • Adverse Experiences

    infusion to 15 days post treatment

Study Arms (2)

1

EXPERIMENTAL
Drug: granisetron

2

EXPERIMENTAL
Drug: granisetron

Interventions

granisetronDRUG

20 micrograms intravenously (iv) 15 min prior to end of surgery

Also known as: Kytril
1

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Fresno, California, 93720, United States

Location

Unknown Facility

Stanford, California, 94305-5118, United States

Location

Unknown Facility

Hartford, Connecticut, 06106, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Indianapolis, Indiana, 46223, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Medical Communications
Organization
Hoffman-LaRoche
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

April 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 27, 2018

Results First Posted

April 28, 2011

Record last verified: 2018-02

Locations

US(11)