Study

Study Type

Participants

Intervention

Outcomes

Comments

Van Egan 1979

Double blind RCT

60 children ages 2 to 6 years

Suppository of domperidone (30 mg),  metoclopramide (10 mg) or placebo given at start of trial and up to 3 times in the subsequent 24 hours

Children treated with domperidone were less likely to require further doses (P=0.055 compared with metaclopramide, P<0.05 compared with placebo). Domperidone was statistically better at reducing nausea, vomiting, anorexia and abdominal pain compared to placebo (P 0.05 or better

No adverse events were identified within the 24 hour study period

Cubeddu 1997

Double blind RCT

36 children ages 6 months to 8 years

Single IV dose of ondansetron (0.3mg/kg), metoclopramide (0.3mg/kg) or placebo (sterile saline)

Children treated with ondansetron had fewer episodes of vomiting in the first 24 hours compared to placebo (P=0.048) and where more likely to have no episdodes of vomiting in the first 24 hours  (P=0.039). More diarrhea was seen in treatment group when compared to placebo (P=0.013 for ondansetron and P=0.004 for metaclopramide)

No difference in the number or type of adverse events reported in the three groups.

Reeves 2002

Double blind RCT

107 children ages 1 month to 22 years

Single IV dose ondansetron (0.15 mg/kg) or placebo (saline)

Children treated with ondansetron were more likely to cease vomiting (70% vs. 51%, P=0.04) and slightly less likely to be admitted to hospital (30% vs. 26%, P=NS).

Only children who required IV therapy were included but the criteria used to make this decision was not outlined in the study. The treatment group was somewhat different than placebo group at the start of the trial in that they were more likely to be younger and have a lower serum pCO2. No significant adverse events were reported during the study period.

Ramscook 2002

Double blind RCT

145 children ages 6 months to 12 years

Liquid ondansetron given every 8 hours for up to 6 doses (1.6 mg/dose for ages 6 months to 1 year, 3.2 mg/dose for ages 1-3 years, 4 mg/dose for ages 4-12 years) or placebo (colour and taste matched)

 

Children treated with ondansetron were more likely to cease vomiting during the ED stay (87% vs 65%, P=0.04) but the difference was not statistically significant over the 48 hour follow up. Children in the treatment group were less likely to need IV therapy (P=0.015) and less likely to be admitted (P=0.007).

Children in the treatment group were more likely to represent to the ED (5% vs 0%, P=0.047) and had more episodes of diarrhea in the first 24 hours (4.7 vs 1.4, P=0.02).

Freedman 2006

Double blind RCT

215 children ages 6 months to 10 years

Single dose oral dissolvable ondansetron (2mg for weights of 8 to 15kg, 4mg for weights greater than 15kg to up to 30kg and 8mg for weights greater than 30kg) or placebo (colour and taste matched)

Children who received ondansetron were less less likely to vomit (14% vs. 35%, RR 0.40, 95% CI 0.26-0.61), tended to vomit less often (0.18 episodes/child vs. 0.65, P<0.001) and have greater oral intake (239 ml vs. 196 ml, P=0.001).

Both the treatment and placebo groups had similar rates of hospitalization (4% vs. 5%, P=1.0). Children in the treatment group had more episodes of vomiting compared with placebo (1.4 vs 0.5, P<0.001). No significant adverse events noted within 7 days.

Stork 2006

Double blind RCT

137 children ages 6 months to 12 years

Single dose IV dexamethasone (1mg/kg, max 15 mg) or ondansetron (0.15 mg/kg) or placebo (all diluted to 10ml)

Admission rates were reduced by ondansetron (4%) and dexamthasone (14%) compared to placebo (21%). The difference was statistically significant for ondansetron compared to placebo (RR=0.21, 95% CI of 0.05 to 0.81).

All groups received IV fluids. The study ended prematurely because of an increased number of patients who had already received antiemetics as outpatients precluding identification of previously untreated patients. No side effects were identified.