NCT02253446已完成4 期
A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea:A Double-Blind, Randomized 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
- 400
- 试验地点
- 1
- 主要终点
- Compare decrease of dysmenorrhea VAS (visual analog scale) score between the two groups. - (First group Piroxicam and Second Diclofenac Sodium)
研究概览
简要总结
- Currently, nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Primary Dysmenorrhea.
- The objective of the study is compare intramuscular Diclofenac sodium and piroxicam's pain reduction dysmenorrhea in emergency department (ED) adults.
- The investigators second aim was to compare recurrent dysmenorrhea pain within 24 hours after discharge.
详细描述
- this is the randomized double blinded clinical trial to compare the efficacy of these two 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 intramuscular drugs (Piroxicam, Diclofenac sodium) 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 Dysmenorrhea 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 two groups:
- First Group: 20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients,
- Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients which determined to be applied as a group.
- Drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not involved in the study.
- Drugs 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 piroxicam, diclofenac sodium 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 intramuscular.
- 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 Dysmenorrhea pain scores.
- Patients in both groups received two types of medication in a similar manner, thus ensuring double blinding.
- Dysmenorrhea pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10
- Rescue medication (100 mg of tramadol hydrochloride) was given intramuscular to patients if pain VAS scores ≥ 5 in forty five 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 45 Years（Adult）
- 性别
- Female
- 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, 45 years or younger
- •had Primary Dysmenorrhea
- •VAS (visual analog scale) score >5.
排除标准
- •Patients with severe liver, kidney and heart failure
- •After the use of aspirin or other nonsteroidal antiinflammatory drugs, asthma, nasal polyps, angioedema and urticaria to be seen
- •To have active peptic ulcer bleeding or perforation
- •Have a history of upper gastrointestinal disease
- •The presence of Phenylketonuria disease
- •To be Pregnancy and breast-feeding
- •To be Asthma patients
- •Have received analgesics in the last 4 hours
- •Patients of childbearing age who are not using a birth control method.
- •The patient who using digoxin, lithium, furosemide and other diuretics, acetylsalicylic acid and anticoagulant coumadin
- •Physical examination and suspected acute abdomen.
研究组 & 干预措施
Diclofenac Sodium
Experimental
Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
干预措施: Diclofenac Sodium (Drug)
Piroksikam
Experimental
20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients,
干预措施: Piroxicam (Drug)
结局指标
主要结局
Compare decrease of dysmenorrhea VAS (visual analog scale) score between the two groups. - (First group Piroxicam and Second Diclofenac Sodium)
时间窗: Change from Baseline in dysmenorrhea pain VAS scores at 60 minutes.
次要结局
未报告次要终点
研究者
Bulent Erdur
professor
Pamukkale University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Comparison of The pain relief of Piroxicam And Transcutaneous Electrical Nerve Stimulation(Tens)Therapy On Orthodontic PaiCTRI/2017/12/010870Manipal College of dental sciences60
已完成
4 期
Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back PainLow Back Pain, MechanicalNCT04609254Pamukkale University210
招募中
不适用
Comparing the effectiveness of shock wave therapy and mesotherapyShoulder Rotator cuff tendinopathy(Non-specific shoulder pain).Pain in unspecified shoulderM25.519IRCT20220903055865N1Shiraz University of Medical Sciences60
尚未招募
4 期
Collation between Piroxicam and Tramadol efficiency after extraction abide by loading of arch wire.CTRI/2024/04/065105DrMadhu Sweta Jain
Unknown
4 期
Intravenous Paracetamol, Dexketoprofen and Ibuprofen in the Treatment of Acute Migraine Attack HeadacheHeadache, MigraineNCT04372264Pamukkale University210