A randomized clinical trial of a single dose of ramosetron for the prevention of vomiting after strabismus surgery in children: a dose-ranging study.
BACKGROUND
Postoperative vomiting (POV) after pediatric strabismus surgery remains a major problem.


OBJECTIVE
To evaluate the efficacy and safety of a single dose of ramosetron, a new serotonin antagonist, for preventing POV in children undergoing strabismus surgery.


METHODS
In a prospective, randomized, double-masked, placebo-controlled study, 80 children (38 boys and 42 girls), aged 4 to 10 years, scheduled for strabismus surgery, received intravenously either placebo or ramosetron at 1 of 3 different doses (3 microg/kg, 6 microg/kg, or 12 microg/kg) (n = 20 each) at the end of the surgical procedure. A standard general anesthetic technique was used.


METHODS
Emetic episodes were recorded and safety assessments performed during the first and second 24-hour periods (ie, 0-24 and 24-48 hours) after receiving anesthesia.


RESULTS
The rate of patients who were emesis-free (defined as no retching and no vomiting), during the 0- to 24-hour period after anesthesia was 35% with 3 microg/kg of ramosetron (P = .37), 90% with 6 microg/kg of ramosetron (P = .001), and 90% with 12 microg/kg of ramosetron (P = .001) compared with placebo (25%). The corresponding rate during the 24- to 48-hour period after anesthesia was 40% (P = .371), 90% (P = .001), and 90% (P = .001), respectively, compared with placebo (30%). No clinically important adverse events were observed in any group.


CONCLUSIONS
A 6-microg/kg dose of ramosetron is sufficient, but a 3-microg/kg dose is insufficient for preventing POV during the 0- to 48-hour period after anesthesia in children undergoing strabismus surgery. Increasing the dose to 12 microg/kg of ramosetron provides no demonstrable additional benefit.
Fujii
Yoshitaka
Y
Department of Anesthesiology, Toride Kyodo General Hospital, Toride City, Ibaraki, Japan. yfujii@md.tsukuba.ac.jp
Tanaka
Hiroyoshi
H
Ito
Mutsuko
M
D000932:Antiemetics / Q000008:administration & dosage* / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D009801:Oculomotor Muscles / Q000601:surgery; D013508:Ophthalmologic Surgical Procedures; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*; D011446:Prospective Studies; D012449:Safety; D012702:Serotonin Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D013285:Strabismus / Q000601:surgery*
D000932:Antiemetics; D001562:Benzimidazoles; D012702:Serotonin Antagonists; C071315:ramosetron