Preemptive Analgesia for Primary Dysmenorrhoea

Preemptive Analgesia for Primary Dysmenorrhoea: a Randomized Controlled Trial

Preemptive analgesia before the release of pain mediators

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Drug: preemptive mefenamic acid; Drug: mefenamic acid

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Mansourah, Egypt, 35516
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the Degree of pain	severity of pain according to visual pain analog scale	4 months

Collaborators and Investigators

• Sponsor: Hanan Nabil
• Investigators: Principal Investigator: Hanan Nabil, MD, Manoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 17, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: primary dysmenorrhea; preemptive analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Mefenamic Acid
• Other Study ID Numbers: 27011975

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No