A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
- Registration Number
- NCT02253446
- Lead Sponsor
- Pamukkale University
- Brief Summary
* 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
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Piroksikam Piroxicam 20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients, Diclofenac Sodium Diclofenac Sodium Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pamukkale Universty
🇹🇷Denizli, Turkey