Preemptive Analgesia for Primary Dysmenorrhoea

Phase 2

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Drug: preemptive mefenamic acid; Drug: mefenamic acid

• Registration Number: NCT03323671
• Lead Sponsor: Hanan Nabil

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

Study Timeline

• Study First Submitted: 2015-10-27
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Status Verified: 2017-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Last Update Submitted: 2017-12-17
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
change in the Degree of pain	4 months	severity of pain according to visual pain analog scale

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansourah, Egypt