NCT02197143已完成4 期
A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- compare the effects of intravenous esomeprazol and ranitidin for the treatment of dyspepsia in the emergency setting.
研究概览
简要总结
- 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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Esomeprazole
Experimental
40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
干预措施: esomeprazole (Drug)
Esomeprazole
Experimental
40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
干预措施: hydrotalcid (Drug)
Ranitidine
Experimental
50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
干预措施: esomeprazole (Drug)
Ranitidine
Experimental
50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
干预措施: Ranitidine (Drug)
placebo
Experimental
150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
干预措施: Ranitidine (Drug)
placebo
Experimental
150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
干预措施: hydrotalcid (Drug)
结局指标
主要结局
compare the effects of intravenous esomeprazol and ranitidin for the treatment of dyspepsia in the emergency setting.
时间窗: Patients in both groups received three types of medication than dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10.
This work took 17 months
次要结局
未报告次要终点
研究者
研究点 (1)
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