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

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ClinicalTrials.gov Identifier: NCT02253446
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bulent Erdur, Pamukkale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Drug: Piroxicam Drug: Diclofenac Sodium Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea:A Double-Blind, Randomized Trial
Study Start Date : May 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Piroksikam
20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients,
 Drug: Piroxicam
20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,
Other Name: Feldene 20 mg/1 mL Solution injectable IM
Experimental: Diclofenac Sodium
Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
 Drug: Diclofenac Sodium
Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
Other Names:
  • DICLOMEC (Solution injectable IM)
  • DIKLORON (Solution injectable IM )
  • MIYADREN (Solution injectable IM )
  • VOLTAREN (Solution injectable IM )


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253446


Locations
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Turkey
Pamukkale Universty
Denizli, Turkey, 20000
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: Mehpare camlibel, MD pamukkale universty
More Information
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Responsible Party: Bulent Erdur, professor, Pamukkale University
ClinicalTrials.gov Identifier: NCT02253446    
Other Study ID Numbers: MDhayri2014
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Keywords provided by Bulent Erdur, Pamukkale University:
Dysmenorrhea
Piroxicam
Diclofenac Sodium
Emergency department
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Diclofenac
Piroxicam
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action