0.5 mg/kg versus 1 mg/kg of Intravenous Omeprazole for the Prophylaxis of Gastrointestinal Bleeding in Critically Ill Children: A Randomized Study - 25/03/13
, Amelia Sánchez, MD 1, César Sánchez, PhD, MD 2, Javier Urbano, MD 1, Dolores López, RN 1, Angel Carrillo, MD, PhD 1
Reprint requests: Jesús López-Herce, PhD, MD, Pediatric Intensive Care Department, Hospital General Universitario Gregorio Marañón, Dr Castelo, 47 28009 Madrid, Spain.Abstract |
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.
Il testo completo di questo articolo è disponibile in PDF.Keyword : AGML, PELOD, PICU, PIM2, PPIs, PRISM
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| Partially supported by the Spanish Health Institute Carlos III (grant RD08/0072: Maternal, Child Health and Development Network) within the framework of the VI National I+D+i Research Program (2008-2011). The authors declare no conflicts of interest. |
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| Trial is registered with European Clinical Trials Database: OM1/2007-006102-19. |
Vol 162 - N° 4
P. 776 - Aprile 2013 Ritorno al numero
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