|
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. |