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

Dyspepsia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

• NCT number: NCT02197143
• Study type: Interventional
• Source: Pamukkale University
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Completion date: July 2014