A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea:A Double-Blind, Randomized Trial

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Drug: Piroxicam
* Drug: Diclofenac Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piroksikam<br>20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients, | Drug: Piroxicam<br>* 20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,<br>* Other names: Feldene 20 mg/1 mL Solution injectable IM;|
| Experimental: Diclofenac Sodium<br>Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients. | Drug: Diclofenac Sodium<br>* Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.<br>* Other names: VOLTAREN (Solution injectable IM );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare decrease of dysmenorrhea VAS (visual analog scale) score between the two groups. - (First group Piroxicam and Second Diclofenac Sodium) |  | Change from Baseline in dysmenorrhea pain VAS scores at 60 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysmenorrhea, Piroxicam, Diclofenac Sodium, Emergency department