Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03697746
Other study ID # Pamukkkale University
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date April 1, 2019

Study information

Verified date October 2018
Source Pamukkale University
Contact SEÇKIN ÇIFTÇIOGLU
Phone 05550619591
Email seckinozyer@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Our study will be performed on 300 patients who meet the criteria for joining the emergency service with primary dysmenorrhea.

3 drugs we will use: 1000 mg vial of paracetamol, dexketoprofen trometamol will be 50 mg ampoule and ibuprofen 400 mg vial

According to the visual analog scale and visual visual scale, we will ask the patient to rate her pain between 0 (no pain) and 10 (the most severe pain of her life).

We aim to determine the superiority of the drugs in passing the pain randomly by giving the 3 drugs that we mentioned to patients with pain above 5.


Description:

Our research will be carried out in Pamukkale University Faculty of Medicine Department of Emergency Medicine in 12 months period. There will be a research assistant and / or a faculty member who will control the research for 24 hours in our emergency department with approximately 110000 adult patients / year.

Study criteria: Female patients with primary dysmenorrhea (abdomino-pelvic pain) in the 18-45 age range. The onset of symptoms should usually be a few hours - 1 day before the onset of visible vaginal bleeding. Possible systemic symptoms such as nausea, vomiting, diarrhea, headache, fatigue, irritability, and dizziness are also questioned and recorded in the data form. Patients with a Visual Analog Scale > 5 and those who require or are recommended nonsteroid antiinflammatory treatment.Patients who come with dysmenorrhea will be randomly selected and will be divided into three groups according to the pre-planned drug administration.

Group 1; Paracetamol 1000 mg Group 2; Dexketoprofen Trometamol 50mg Group 3; Ibuprofen 400 mg In the form of group to be administered intravenously. In case of unresponsiveness to treatment, intravenous Tramadol hcl 100mg will be administered after 45 minutes.

Pain scores of patients will be recorded using the Visual Analog Scale, 0-10 cm Visual Analog Scale, to score the degree of pain.During the process, O2 saturation monitorization, automatic manometer (blood pressure), rhythm monitorization (speed and rhythm) will be provided and all other medications during the operation will be recorded.

Pain scores will be recorded at 0, 15, 30, 45 and 60 minutes. In addition, heart rate, systolic blood pressure, diastolic blood pressure, respiration rate and O2 saturation (SPO2) will be recorded at 0, 15, 30, 60 minutes.

In addition, any side effects that may occur are recorded in the data sheet. If side effects are necessary, treatment will be applied. All information will be saved to the created work form


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Female patients with primary dysmenorrhea (abdomino-pelvic pain) between the ages of 18-45.

- The onset of symptoms should usually be a few hours - 1 day before the onset of visible vaginal bleeding.

- Possible systemic symptoms such as nausea, vomiting, diarrhea, headache, fatigue, irritability, and dizziness are also questioned and recorded in the data form.

- Patients with visual analogue scale score> 5 and those who need or need nonsteroidal anti-inflammatory treatment.

Exclusion Criteria:

- Severe liver, kidney and heart failure; asthma, nasal polyp, angioedema and urticaria against aspirin or other nonsteroidal antiinflammatory drugs;

- Active peptic ulcer, bleeding or perforation; to have a history of upper gastrointestinal disease;

- Patients with phenylketonuria;

- During pregnancy and lactation;

- Have asthma;

- Have taken analgesics in the last 4 hours;

- The age of pregnancy and not using birth control method; digoxin, lithium, furosemide and other diuretics, acetylsalicylic acid and coumarin group using anticoagulants and physical examination of the suspicion of acute abdomen and signs of peritoneal irritation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
paracetamol
paracetamol 1000 mg vial
Dexketoprofen Trometamol
dexketoprofen trometamol 50 mg bulb
Ibuprofen
ibuprofen 400 mg vial

Locations

Country Name City State
Turkey Pamukkale University Deni?zli?

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ayan M, Tas U, Sögüt E, Arici S, Karaman S, Esen M, Demirtürk F. [Comparing efficiencies of diclofenac sodium and paracetamol in patients with primary dysmenorrhea pain by using Visual Analog Scale]. Agri. 2013;25(2):78-82. doi: 10.5505/agri.2013.42103. Turkish. — View Citation

Iacovides S, Baker FC, Avidon I. The 24-h progression of menstrual pain in women with primary dysmenorrhea when given diclofenac potassium: a randomized, double-blinded, placebo-controlled crossover study. Arch Gynecol Obstet. 2014 May;289(5):993-1002. doi: 10.1007/s00404-013-3073-8. Epub 2013 Nov 5. — View Citation

Letzel H, Mégard Y, Lamarca R, Raber A, Fortea J. The efficacy and safety of aceclofenac versus placebo and naproxen in women with primary dysmenorrhoea. Eur J Obstet Gynecol Reprod Biol. 2006 Dec;129(2):162-8. Epub 2006 May 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary item pain intensity measure the patient will be given medication and will be asked to score between 0 and 10 on a visual analog scale.(0=no pain, 10= pain as bad as can be) every 15 minutes within 1 hour 1 hour
Primary item pain intensity measure 100 mg of tramadol hcl will be given when the patient's pain does not fall below 5 points on a visual analog scale. 15 minute
See also
  Status Clinical Trial Phase
Completed NCT04607382 - Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT00746096 - Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea Phase 3
Completed NCT00769964 - VA111913 TS: First in Human Study Phase 1
Completed NCT00104546 - Vitamin K Injections for the Treatment of Painful Menstruation Phase 1
Completed NCT06011928 - MOPEXE and RE in Treating Dysmenorrhea N/A
Not yet recruiting NCT06398990 - The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea N/A
Recruiting NCT02031523 - Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis Phase 4
Completed NCT01449305 - Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea N/A
Completed NCT00995917 - A Pilot Study of Acupoint Injection for Primary Dysmenorrhea N/A
Completed NCT02910167 - Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
Not yet recruiting NCT05461846 - Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Recruiting NCT03394547 - Pulsed Electromagnetic Field Treatment for Painful Periods N/A
Recruiting NCT06294743 - Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea Early Phase 1
Active, not recruiting NCT01738204 - The Women's Health Study: From Adolescence to Adulthood
Completed NCT01462370 - Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1) Phase 3
Completed NCT01250587 - Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea Phase 1
Completed NCT00951561 - A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen N/A
Completed NCT03972917 - Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy