Preemptive Analgesia for Primary Dysmenorrhoea

Overview

Preemptive analgesia before the release of pain mediators

Full Title of Study: “Preemptive Analgesia for Primary Dysmenorrhoea: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2017

Detailed Description

spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea. Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea. Getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia

Interventions

  • Drug: preemptive mefenamic acid
    • preemptive analgesia before menstrual pain
  • Drug: mefenamic acid
    • mefenamic acid given only during menstruation

Arms, Groups and Cohorts

  • Experimental: premenstruation group
    • preemptive mefenamic acid 500mg tablets every 8 hours starting 2 days before anticipated menstruation and during the first 2 days of the cycle
  • Experimental: menstruation group
    • mefenamic acid 500mg tablets every 8 hours during the first 2 days of the cycle

Clinical Trial Outcome Measures

Primary Measures

  • change in the Degree of pain
    • Time Frame: 4 months
    • severity of pain according to visual pain analog scale

Participating in This Clinical Trial

Inclusion Criteria

  • nulliparous ladies – with regular menstrual cycle pattern – those experienced history of dysmenorrhea (primary or spasmodic) – patients able to sallow tables Exclusion Criteria:

  • irregular cycles – any associated local causes( pelvic infection, endometriosis, fibroid or others) – patients with familial Mediterranean fever or other intermenstrual attacks of abdominal pain – gastric or duodenal ulcers or gastritis – other contraindications to non steroidal anti-inflammatory drugs – patients with severe diminution of vision or color discrimination – patients with any depressive or mood disorders – patients receiving any hormonal treatment

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hanan Nabil
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Hanan Nabil, Associate Professor Obstetrics and Gynecology – Mansoura University
  • Overall Official(s)
    • Hanan Nabil, MD, Principal Investigator, Manoura University Hospital

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