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

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253446
• Other study ID #: MDhayri2014
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2014
• Last updated: September 27, 2014
• Start date: May 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device InstitutionTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Drug:
• Piroxicam
20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,
• Diclofenac Sodium
Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Locations

Country	Name	City	State
Turkey	Pamukkale Universty	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No