a comparison of efficacy of intravenous esomeprazole and ranitidine treatment of dyspeptic pain

Conditions: Dyspepsia

Summary: * currently, proton pump inhibitors and h2receptor blockers are widely used by emergency physicians in turkey for the treatment of patients with dyspepsia. * the objective of the study was to assess whether intravenous esomeprazol has superior dyspeptic pain reduction compared with ranitidine or hydrotalcid in emergency department (ed) adults * the investigators second aim was to compare recurrent dyspeptic pain within 24 hours after discharge and cost of treatments in the treatment of dyspepsia.

* this is the placebo randomized double blinded clinical trial to compare the efficacy of these three drugs in this clinical setting. * a randomized clinical trial was conducted in the ed of pamukkale university medical faculty hospital * study personnel (emergency physicians and nurses) were trained before the study. * when intravenous drugs (esomeprazol, ranitidine or plasebo) was being recommended, an eligibility checklist was completed by the attending physician. * if there were no exclusion criteria, written informed consent was obtained and baseline information, including initial dispeptic pain severity ratings with vas were recorded. * the need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients. * all patients eligible for the study were randomized to one of three groups: * first group: 40 mg esomeprozol with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml hidrotalcid * second group: 50mg ranitidin with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml hidrotalcid * third group: 150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml hidrotalcid * drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not involved in the study. * drug packs were prepared according to the computer-generated random number sequence to assign treatment allocations * the allocation list was kept by the emergency nurse. patients received the esomeprazol, the ranitidin or the placebo medication schemes according to their random allocations. * after enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered as a infusion over 15 minutes. * randomization was achieved by using computer software to generate random numbers. during the intervention, participants were monitored by an oxygen saturation (spo2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms) * one researcher blinded to patient allocation observed the whole procedure and recorded the dyspeptic pain scores. * patients in both groups received three types of medication in a similar manner (for example, 150 ml normal saline given as a slow intravenous infusion over 15 minutes), thus ensuring double blinding. * dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a vas of 1 to 10 * rescue medication \[hidrotalcid 10ml (talcid, bayer, istanbul, turkey)\] was given intravenously to patients if dyspeptic pain vas scores ≥ 5 in thirty minutes after study drug administration. * all other medications required during the study also were recorded. * during the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (spo2) were recorded at baseline (0 min), 15, 30, and 60 min.

Eligibility criteria:
inclusion criteria: * patients were eligible for inclusion if they were aged 18 years or older, 60 years or older, * had dyspspsia \[vas (visual analog scale) score \>5\] during their ed episode of care for which the attending physician recommended medication. exclusion criteria: * pretreatment 100-mm linear visual analog scale (vas) pain score less than 50 mm; * known cases of malignancy or terminal illness; * known cases of major medical problems (eg, any evidence of active structural or functional abnormality of the hearts, chronic renal failure) * allergy or previous adverse reaction to study drugs studied * received agents to inhibit the secretion of acid (ppis or histamine-2 receptor antagonists), nonsteroidal anti-inflammatory drugs, * who consumed alcohol within 4 hours before the ed visit * diarrhea more than 2 times within the past 24 hours; * being suspected to have other ed diagnoses (eg, gut obstruction, biliary colic, pancreatitis, hepatitis, or localized hepatobiliary infections); * being pregnant or breast-feeding; and * inability to comprehend the vas evaluation. * and patients who refused to participate study.

Keywords: esomeprazole ranitidine hydrotalcid treatment of dyspepsia emergancy medicine