A randomized, pharmacokinetic and pharmacodynamic, cross-over study of duodenal or jejunal administration compared to nasogastric administration of omeprazole suspension in patients at risk for stress ulcers

OBJECTIVES: The aim of this study was to characterize absorption and pH con trol of simplified omeprazole sus]pension (SOS), 2 mg/ml in 8.4% sodium bic arbonate, administered via the nasogastric versus jejunal or duodenal route . METHODS: Nine critically ill surgical patients, NPO and mechanically ventil ated, were enrolled in this randomized cross-over study. Patients received a single 40 mg dose of SOS by the nasogastric and either the jejunal or duo denal route. Twenty-four-hour continuous intragastric pH monitoring was per formed during the study period. Sequential blood samples were collected ove r 24 h to characterize SOS absorption and pharmacokinetic parameters. RESULTS: Nasogastric administration of SOS resulted in lower maximum mean /- SD serum concentrations compared to jejunal/duodenal dosing (0.970 +/- 0 .436 vs 1.833 +/- 0.416 mug/ml, p = 0.006). SOS absorption was significantl y slower when administered via nasogastric tube (108.3 +/- 42.0 vs 12.1 +/- 7.9 min, p < 0.001). However, all routes of administration resulted in sim ilar SOS area under the serum concentration-time curves (AUC(0-<proportiona l to>)) (415.1 +/- 291.8 vs 396.7 +/- 388.1 mug . h/ml, p = 0.91). Mean int ragastric pH values remained >4 at 1 h after SOS administration and remaine d >4 for the entire 24-h study (6.32 +/- 1.04, 5.57 +/- 1.15, nasogastric v s jejunal/duodenal, p = 0.015), regardless of administration route. CONCLUSIONS: In critically ill surgical patients, pharmacokinetic parameter s and subsequent pH control after the administration of SOS are similar by the jejunal, nasogastric. or duodenal route. SOS suspension offers an alter native acid control measure when patients are unable to take oral medicatio ns, yet have an enteral tube in place.