Abstract | BACKGROUND: OBJECTIVE: METHODS: Standard general anesthetic technique and postoperative analgesia were used in this prospective, randomized, double-blind, placebo-controlled, dose-ranging trial of pediatric patients. Patients who had experienced POV, had taken an antiemetic medication within 24 hours before surgery of had a history of motion sickness were excluded. Only patients aged 4 to 10 years were included, because of their ability to answer questions. Patients received a single administration of either i.v. placebo or i.v. ramosetron at 3, 6, or 12 microg/kg immediately after the end of surgery. During the first 48 hours after anesthesia, episodes of retching, vomiting, and adverse events were recorded by nursing staff blinded to treatment assignment. RESULTS: Eighty children (20 in each group)--42 girls and 38 boys--were enrolled. There were no differences in patient demographic characteristics among the treatment groups. The rates of complete response (no vomiting, retching, or need for another antiemetic medication) from 0 to 24 hours after anesthesia were 35% (7/20) with ramosetron 3 microg/kg, 90% (18/20) with ramosetron 6 micro/kg, and 90% (18/20) with ramosetron 12 microg/kg compared with placebo (30% [620], P=NS, P=0.001, and P=0.001 vs placebo, respectively); the corresponding rates from 24 to 48 hours after anesthesia were 35% (7/20), 90% (18/20), and 95% (19/20) compared with placebo (35% [7/20]; P=NS, P=0.001, and P=0.001 vs placebo, respectively). No difference in antiemetic efficacy was observed between ramosetron 6 and 12 microg/kg. No clinically serious adverse events attributable to the study drug were observed in any group. CONCLUSIONS: In the pediatric population studied, ramosetron 6 microg/kg was effective for the prevention of vomiting after tonsillectomy from 0 to 48 hours after anesthesia. Increasing the dose to 12 microg/kg did not appear to provide further benefit.
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Authors | Yoshitaka Fujii, Hiroyoshi Tanaka |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 25
Issue 12
Pg. 3135-42
(Dec 2003)
ISSN: 0149-2918 [Print] United States |
PMID | 14749151
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Retracted Publication)
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Chemical References |
- Antiemetics
- Benzimidazoles
- ramosetron
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Topics |
- Antiemetics
(therapeutic use)
- Benzimidazoles
(therapeutic use)
- Child
- Child, Preschool
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Injections, Intravenous
- Male
- Postoperative Nausea and Vomiting
(prevention & control)
- Prospective Studies
- Tonsillectomy
- Treatment Outcome
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