The Effectiveness of Adding Magnesium Sulfate to Tincture of Opium and Buprenorphine on Pain and Quality of Life in Women with Dysmenorrhea: a Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical, the Results of a Six-Month Follow-up

Phase 1

Completed

• Conditions: The short duration of the follow- up and the small size of the sample are among the limitations of our study. The use of self- reporting tool can also be associated with bias in respondents. It is sugge; Dysmenorrhea, Endometriosis, Pain, Magnesium sulfate, Buprenorphine, Tincture of Opium

• Registration Number: TCTR20190329001
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-06-01
• Study Start: 2019-03-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 163

Inclusion Criteria

The inclusion criteria were: aged 18-45 years, the presence of regular menstrual cycle, features of pelvic endometriosis (posterior, middle and anterior compartments) and/ or adenomyosis according to the revised American Society for Reproductive Medicine (ASRM) classification and the presence of ovarian endometrioma or uterine adenomyosis at clinical and transvaginal ultrasound (TV-US), taking 2-4 cc of TOP and 2-4 mg Buprenorphine Sublingual.

Exclusion Criteria

Exclusion criteria were: Hypersensitivity to magnesium sulfate, 18>BMI>35, previous surgical treatment, hormonal therapy in the last 6 months, use of drugs affecting Neuromuscular Function, history of renal disease, hepatitis, current pregnancy, major medical illnesses, Spinal disease, neuropathy, hypomagnesemia (serum magnesium concentration < 1.8 mg/dL); hypermagnesemia (serum magnesium concentration> 2.6 mg/dL); taking Calcium-channel blockers (CCBs), AV block degree II or III, systolic blood pressure < 90 mmHg, body temperature > 38 °C, history of heart disease, Liver failure, respiratory disease, renal failure, gastrointestinal bleeding, metabolic disorder, active peptic ulcer, and seizure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain 24-week Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
quality of life 24-week Quality of life questionnaire