Preemptive Analgesia for Primary Dysmenorrhoea

Sponsor

Hanan Nabil (Other)

Overall Status

Completed

CT.gov ID

NCT03323671

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Preemptive analgesia before the release of pain mediators

Condition or Disease	Intervention/Treatment	Phase
Primary Dysmenorrhea	Drug: preemptive mefenamic acid Drug: mefenamic acid	Phase 2/Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Preemptive Analgesia for Primary Dysmenorrhoea: a Randomized Controlled Trial

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: preemptive mefenamic acid preemptive analgesia before menstrual pain Other Names: ponstan forte
Experimental: menstruation group mefenamic acid 500mg tablets every 8 hours during the first 2 days of the cycle	Drug: mefenamic acid mefenamic acid given only during menstruation Other Names: ponstan forte

Arm

Intervention/Treatment

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

Drug: preemptive mefenamic acid

preemptive analgesia before menstrual pain

Other Names:

ponstan forte

Experimental: menstruation group

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

Drug: mefenamic acid

mefenamic acid given only during menstruation

Other Names:

ponstan forte

Outcome Measures

Primary Outcome Measures

change in the Degree of pain [4 months]
severity of pain according to visual pain analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansourah		Egypt	35516

Sponsors and Collaborators

Hanan Nabil

Investigators

Principal Investigator: Hanan Nabil, MD, Manoura University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanan Nabil, Associate Professor Obstetrics and Gynecology, Mansoura University

ClinicalTrials.gov Identifier:

NCT03323671

Other Study ID Numbers:

27011975

First Posted:

Oct 27, 2017

Last Update Posted:

Dec 19, 2017

Last Verified:

Dec 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hanan Nabil, Associate Professor Obstetrics and Gynecology, Mansoura University

primary dysmenorrhea

preemptive analgesia

Additional relevant MeSH terms:

Dysmenorrhea

Mefenamic Acid

Study Results

No Results Posted as of Dec 19, 2017