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

NCT ID: NCT02253446

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-07-31

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Piroksikam

20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients,

Group Type: EXPERIMENTAL

Piroxicam

Intervention Type: DRUG

20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,

Diclofenac Sodium

Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Group Type: EXPERIMENTAL

Diclofenac Sodium

Intervention Type: DRUG

Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Interventions

Piroxicam

20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,

Intervention Type: DRUG

Diclofenac Sodium

Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Intervention Type: DRUG

Other Intervention Names

Feldene 20 mg/1 mL Solution injectable IM; DICLOMEC (Solution injectable IM); DIKLORON (Solution injectable IM ); MIYADREN (Solution injectable IM ); VOLTAREN (Solution injectable IM )

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Bulent Erdur

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehpare camlibel, MD

Role: PRINCIPAL_INVESTIGATOR

pamukkale universty

Locations

Pamukkale Universty

Denizli, Denizli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MDhayri2014

Identifier Type: -

Identifier Source: org_study_id