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Gastrointestinal Disease Therapeutics Working Group Documents Acid suppressing drugs in children (to include zantac, prilosec, pantoprazole, lansoprazole, omeprazole); Clinical trials and some reviews. July 22, 2010 130 citations with abstracts 1. Aanpreung, P., Vanprapar, N., Susiva, C., Parkpreaw, C., and Boonyachart, C. A randomized clinical trial comparing the efficacy of ranitidine and famotidine on intragastric acidity in critically ill pediatric patients. J Med Assoc Thai 81: 185- 189, 1998. We examined the efficacy of intravenous ranitidine and famotidine on raising intragastric pH in each of 10 critically ill pediatric patients. The severity of illness was assessed by using the modified zinner index score. The study had 3 phases and each phase took 24 hours. Intragastric pH was measured by continuous pH monitoring digitrapper for 72 hours. In phase 1 and 3, the patients did not receive any H2 blockers. In phase 2, they were randomized to receive intravenous ranitidine or famotidine. The majority of cases had intragastric pH < 4 in day 1 (base line). Ranitidine and famotidine increased total time of intragastric pH > or = 4 from the base line during day 2, 38.2 +/- 16.9 per cent and 60.3 +/- 24.8 per cent respectively (P0.004), but there was no statistical difference between the 2 medications in both Zinner index score 1 and score greater than 1 group (P 0.08, 0.45). Three cases in the famotidine group had successful prophylaxis with total time pH > or = 4 more than 80 per cent. Famotidine appeared to have a trend toward increasing intragastric pH in critically ill pediatric patients. 2. Ameen, V.Z., Pobiner, B.F., Giguere, G.C., and Carter, E.G. Ranitidine (Zantac) syrup versus Ranitidine effervescent tablets (Zantac) EFFERdose) in children: a single-center taste preference study. Paediatr Drugs 8: 265-270, 2006. BACKGROUND: The histamine H(2) receptor antagonist ranitidine is US FDA- approved for the treatment of gastroesophageal reflux disease and healing of erosive esophagitis in children >or=1 month of age. A low-dose strength of ranitidine is now available in a citrus-flavored 25 mg effervescent tablet (dissolved in 5 mL of water); this formulation was developed to facilitate use in infants and smaller children. Ranitidine syrup is available in a peppermint- flavored 15 mg/mL formulation. OBJECTIVE: To compare taste preferences for ranitidine (Zantac) syrup and ranitidine effervescent tablets dissolved in water (Zantac EFFERdose) in healthy children aged 4-8 years and their adult caregivers. STUDY DESIGN AND METHODS: A randomized, single-blind, crossover, taste test trial was conducted in 102 children and 102 parents/legal guardians. All subjects received a single 45 mg dose of each formulation. After tasting both preparations children were asked: "Now that you have tasted both medicines, which one of these medicines do you think tastes better?" Adults were asked four questions to assess whether they would administer the medication to the children. RESULTS: Seventy-one percent (72/102) of the children preferred the taste of the ranitidine effervescent tablets compared with 29% (30/102) who preferred the syrup (p < 0.001). The majority of adults (71%) responded that they would prefer to administer the effervescent formulation based on taste. Adverse events consistent with product labeling were mild and were reported in four children and three adults: headache (n = 3), drowsiness (n = 1), abdominal pain/cramps (n = 2), and bloating/gas (n = 1). CONCLUSION: The taste of the ranitidine effervescent formulation dissolved in water is preferred over the ranitidine syrup. Better taste acceptance may facilitate ease of administration and compliance in pediatric patients. 3. Andersson, T., Hassall, E., Lundborg, P., Shepherd, R., Radke, M., Marcon, M., Dalvag, A., Martin, S., Behrens, R., Koletzko, S., Becker, M., Drouin, E., and Gothberg, G. Pharmacokinetics of orally administered omeprazole in children. International Pediatric Omeprazole Pharmacokinetic Group. Am J Gastroenterol 95: 3101-3106, 2000. OBJECTIVES: The aim of this study was to examine the pharmacokinetics of orally administered omeprazole in children. METHODS: Plasma concentrations of omeprazole were measured at steady state over a 6-h period after administration of the drug. Patients were a subset of those in a multicenter study to determine the dose, safety, efficacy, and tolerability of omeprazole in the treatment of erosive reflux esophagitis in children. Children were 1-16 yr of age, with erosive esophagitis and pathological acid reflux on 24 h-intraesophageal pH study. The "healing dose" of omeprazole was that at which subsequent intraesophageal pH study normalized. Children remained on this dose for 3 months, and during this period the pharmacokinetics were measured. RESULTS: A total of 57 children were enrolled in the overall healing phase of the study. Pharmacokinetic study was optional for subjects and was performed in 25 of the 57 enrolled. The doses of omeprazole required were substantially higher doses per kilogram of body weight than in adults. Values of the pharmacokinetic parameters of omeprazole were generally within the ranges previously reported in adults. However, the plasma levels, area under the plasma concentration versus time curve (AUC), plasma half-life (t(1/2)), and maximal plasma concentration (Cmax), were lower in the younger age group, when the AUC and Cmax were normalized to a dose of 1 mg/kg. Furthermore, within the group as a whole, these values showed a gradation from lowest in the children 1-6 yr of age to higher in the older age groups. CONCLUSIONS: The pharmacokinetics of omeprazole in children showed a trend toward higher metabolic capacity with decreasing age, being highest at 1-6 yr of age. This may explain the need for higher doses of omeprazole on a per kilogram basis, not only in children overall compared with adults but, in many cases, particularly in younger children. 4. Apte, N.M., Karnad, D.R., Medhekar, T.P., Tilve, G.H., Morye, S., and Bhave, G.G. Gastric colonization and pneumonia in intubated critically ill patients receiving stress ulcer prophylaxis: a randomized, controlled trial. Crit Care Med 20: 590-593, 1992. OBJECTIVE: To study the effects of pharmacologically increasing gastric pH on gastric colonization and the development of pneumonia in intubated critically ill patients. DESIGN: Randomized, controlled trial. SETTING: Medical ICU in a university hospital. PATIENTS: Thirty-four tracheotomized patients with tetanus. INTERVENTIONS: Sixteen patients received iv ranitidine to increase gastric pH greater than 4 (ranitidine group), while 18 patients received no prophylaxis for upper gastrointestinal bleeding (control group). MEASUREMENTS AND MAIN RESULTS: Mean gastric pH was higher in the ranitidine group (median 4.7, range 3.6 to 6.1) than in the control group (median 2.1, range 1.2 to 4.9; p less than .05). Gastric colonization occurred in 15 (94%) of 16 patients who received ranitidine, 2 days (median; range 1 to 5) after intubation; gastric colonization also occurred in all control patients (median 4 days, range 1 to 9; p less than .05). Pneumonia occurred in 13 (81%) of 16 patients who received ranitidine, 3 days (median, range 1 to 5) after intubation and in nine (50%) of 18 control patients (p less than .01) 5 days after tracheal intubation (median, range 3 to 14; p less than .01). Prior gastric colonization by the pathogen that caused pneumonia was demonstrable in nine (56%) of 16 patients who received ranitidine vs. eight (44%) of 18 control patients (p greater than .05). The risk for developing pneumonia in the ranitidine-treated group was highest in the first 4 days after tracheal intubation. There was no difference in the frequency of upper gastrointestinal hemorrhage in the two groups. CONCLUSIONS: Pharmacologically increasing gastric pH increases the risk for developing pneumonia in intubated critically ill patients. The pneumonia occurs earlier than in untreated control patients. 5. Ashorn, M., Rago, T., Kokkonen, J., Ruuska, T., Rautelin, H., and Karikoski, R. Symptomatic response to Helicobacter pylori eradication in children with recurrent abdominal pain: double blind randomized placebo-controlled trial. J Clin Gastroenterol 38: 646-650, 2004. BACKGROUND: Controlled trials considering the effect of Helicobacter pylori (H. pylori) eradication on gastrointestinal symptoms in children are scant. We aimed to study the connection between recurrent abdominal pain and dyspepsia and H. pylori infection in children. STUDY: This was a double blind randomised controlled trial. Twenty children with recurrent abdominal pain (RAP) being H. pylori positive as measured with the C urea breath test (UBT) were randomized either to receive omeprazole, amoxycillin and clarithromycin (n = 10), or omeprazole and 2 placebos (n = 10) for 1 week after gastroscopy. Symptoms were registered prior to the treatment and at follow up visits 2, 6, 24, and 52 weeks after stopping the treatment. Control UBT was performed on all patients 6 weeks post-treatment and again at the 52 week follow-up visit, when also re- endoscopy with biopsies was done to all participants. RESULTS: All infected children had histologic gastritis. Bacterial eradication was achieved in 8/10 in the triple treatment group and in none in the placebo group. There was no change in symptom index in either group at 2 weeks post treatment. At 52 weeks a similar reduction in symptom index was observed in both groups irrespective of the healing of gastritis, which was more commonly achieved along the eradication. CONCLUSIONS: Bacterial eradication and healing of gastric inflammation does not lead to symptomatic relief of chronic abdominal pain in children. 6. Ashorn, M., Ruuska, T., and Makipernaa, A. Helicobacter pylori and iron deficiency anaemia in children. Scand J Gastroenterol 36: 701-705, 2001. BACKGROUND: Both iron deficiency anaemia and Helicobacter pylori infection are rare in developed countries. A possible connection has been suggested between these two diseases and our aim was to define the clinical picture and to study the effect of bacterial eradication in H.
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