OBJECTIVE: To compare the effect of 2 doses of intravenous omeprazole on gastric pH, gastrointestinal bleeding, and adverse effects in critically ill children. STUDY DESIGN: We undertook a prospective randomized clinical trial in critically ill children at risk of gastrointestinal bleeding. The effect of 2 intravenous omeprazole regimens (0.5 or 1 mg/kg every 12 hours) on the gastric pH and incidence of gastrointestinal hemorrhage was compared. The efficacy criteria were a gastric pH >4 and the absence of clinically significant gastrointestinal bleeding. RESULTS: Forty patients, 20 in each treatment group, were studied. Overall, the gastric pH was greater than 4 for 57.8% of the time, with no difference between the doses (P = .66). The percentage of time with a gastric pH > 4 increased during the study (47.8% between 0 and 24 hours vs 76% between 24 and 48 hours, P = .001); the greater dose showed a greater increase in the percentage of time with a pH > 4: between hours 24 and 48 of the study, the gastric pH was greater than 4 for 84.5% of the time with the 1 mg/kg dose and for 65.5% of the time with the 0.5 mg/kg dose (P = .036). Plasma omeprazole levels were greater with 1 mg/kg dose, but no correlation was found between omeprazole plasma levels and gastric pH. No toxic adverse effects were detected, and there was no clinically significant bleeding. CONCLUSION: Neither of the 2 omeprazole regimens achieved adequate alkalinization of the gastric pH during the first 24 hours. Between 24 and 48 hours, the 1 mg/kg dose maintained the gastric pH greater than 4 for a greater percentage of the time.
RCT Entities:
OBJECTIVE: To compare the effect of 2 doses of intravenous omeprazole on gastric pH, gastrointestinal bleeding, and adverse effects in critically ill children. STUDY DESIGN: We undertook a prospective randomized clinical trial in critically ill children at risk of gastrointestinal bleeding. The effect of 2 intravenous omeprazole regimens (0.5 or 1 mg/kg every 12 hours) on the gastric pH and incidence of gastrointestinal hemorrhage was compared. The efficacy criteria were a gastric pH >4 and the absence of clinically significant gastrointestinal bleeding. RESULTS: Forty patients, 20 in each treatment group, were studied. Overall, the gastric pH was greater than 4 for 57.8% of the time, with no difference between the doses (P = .66). The percentage of time with a gastric pH > 4 increased during the study (47.8% between 0 and 24 hours vs 76% between 24 and 48 hours, P = .001); the greater dose showed a greater increase in the percentage of time with a pH > 4: between hours 24 and 48 of the study, the gastric pH was greater than 4 for 84.5% of the time with the 1 mg/kg dose and for 65.5% of the time with the 0.5 mg/kg dose (P = .036). Plasma omeprazole levels were greater with 1 mg/kg dose, but no correlation was found between omeprazole plasma levels and gastric pH. No toxic adverse effects were detected, and there was no clinically significant bleeding. CONCLUSION: Neither of the 2 omeprazole regimens achieved adequate alkalinization of the gastric pH during the first 24 hours. Between 24 and 48 hours, the 1 mg/kg dose maintained the gastric pH greater than 4 for a greater percentage of the time.