A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): esomeprazole; Ranitidine; hydrotalcid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid; 50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid; 150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other intervention name(s): Nexium, Astra Zeneca drugs, Södertalje; Esmara; Esom; Ulcuran, Abfar drugs, Istanbul; Ranitab; Ultidin; Talcid, Bayer, Istanbul
Intervention MeSH terms: Esomeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: esomeprazole; ranitidine; hydrotalcid; treatment of dyspepsia; emergancy medicine