title: 0.5 mg/kg versus 1 mg/kg of intravenous omeprazole for the prophylaxis of gastrointestinal bleeding in critically ill children: a randomized study.
abstract: OBJECTIVE
  To compare the effect of 2 doses of intravenous omeprazole on gastric pH, gastrointestinal bleeding, and adverse effects in critically ill children.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatric Intensive Care Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Maria José
authors.initials: MJ
authors.lastname: Solana
authors.forename: Jesús
authors.initials: J
authors.lastname: López-Herce
authors.forename: Amelia
authors.initials: A
authors.lastname: Sánchez
authors.forename: César
authors.initials: C
authors.lastname: Sánchez
authors.forename: Javier
authors.initials: J
authors.lastname: Urbano
authors.forename: Dolores
authors.initials: D
authors.lastname: López
authors.forename: Angel
authors.initials: A
authors.lastname: Carrillo
mesh_terms: D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000493:pharmacokinetics; D002648:Child; D002675:Child, Preschool; D016638:Critical Illness; D005260:Female; D005745:Gastric Acidity Determination; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000517:prevention & control*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007223:Infant; D007262:Infusions, Intravenous / Q000379:methods*; D008297:Male; D009853:Omeprazole / Q000008:administration & dosage* / Q000493:pharmacokinetics; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D009853:Omeprazole