NCT02197143

A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain

A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Pamukkale University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* 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.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	esomeprazole	40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
DRUG	Ranitidine	50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
DRUG	hydrotalcid	150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-07-22
• Last updated: 2014-07-22

Locations

1 site across 1 country: Turkey (Türkiye)