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NCT Number: NCT00231478

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

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.

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Key information

Conditions

Post-operative Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granisetron

Drug

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

Other names: Kytril

Primary outcomes

  1. Number of Patients With no Vomiting

    Time frame: 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 outcomes

  1. Number of Patients With no Vomiting

    Time frame: 0-24h after time of extubation

    No vomiting describes no emesis during the first 24 hours

  2. Time to First Vomiting Episode

    Time frame: 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

    Time frame: infusion to 15 days post treatment

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 4, 2005
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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