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Preemptive Analgesia for Primary Dysmenorrhoea

NCT ID: NCT03323671

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-12-01

Brief Summary

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Preemptive analgesia before the release of pain mediators

Detailed Description

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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

Conditions

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Primary Dysmenorrhea

Keywords

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primary dysmenorrhea preemptive analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

preemptive mefenamic acid

Intervention Type DRUG

preemptive analgesia before menstrual pain

menstruation group

mefenamic acid 500mg tablets every 8 hours during the first 2 days of the cycle

Group Type EXPERIMENTAL

mefenamic acid

Intervention Type DRUG

mefenamic acid given only during menstruation

Interventions

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preemptive mefenamic acid

preemptive analgesia before menstrual pain

Intervention Type DRUG

mefenamic acid

mefenamic acid given only during menstruation

Intervention Type DRUG

Other Intervention Names

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ponstan forte ponstan forte

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hanan Nabil

OTHER

Sponsor Role lead

Responsible Party

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Hanan Nabil

Associate Professor Obstetrics and Gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hanan Nabil, MD

Role: PRINCIPAL_INVESTIGATOR

Manoura University Hospital

Locations

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Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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27011975

Identifier Type: -

Identifier Source: org_study_id