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Preemptive Analgesia for Primary Dysmenorrhoea

Primary Purpose

Primary Dysmenorrhea

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

preemptive mefenamic acid

mefenamic acid

About this trial

This is an interventional supportive care trial for Primary Dysmenorrhea focused on measuring primary dysmenorrhea, preemptive analgesia

Eligibility Criteria

15 Years - 25 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

premenstruation group

menstruation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in the Degree of pain

severity of pain according to visual pain analog scale

Secondary Outcome Measures

Full Information

NCT ID

NCT03323671

First Posted

October 27, 2015

Last Updated

December 17, 2017

Sponsor

Hanan Nabil

1. Study Identification

Unique Protocol Identification Number

NCT03323671

Brief Title

Preemptive Analgesia for Primary Dysmenorrhoea

Official Title

Preemptive Analgesia for Primary Dysmenorrhoea: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

December 1, 2017 (Actual)

Study Completion Date

December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hanan Nabil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Preemptive analgesia before the release of pain mediators

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Dysmenorrhea

Keywords

primary dysmenorrhea, preemptive analgesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

premenstruation group

Arm Type

Experimental

Arm Description

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

Arm Title

menstruation group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

preemptive mefenamic acid

Other Intervention Name(s)

ponstan forte

Intervention Description

preemptive analgesia before menstrual pain

Intervention Type

Drug

Intervention Name(s)

mefenamic acid

Other Intervention Name(s)

ponstan forte

Intervention Description

mefenamic acid given only during menstruation

Primary Outcome Measure Information:

Title

change in the Degree of pain

Description

severity of pain according to visual pain analog scale

Time Frame

4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanan Nabil, MD

Organizational Affiliation

Manoura University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura University

City

Mansourah

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

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Preemptive Analgesia for Primary Dysmenorrhoea

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