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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190329001
Enrollment
Unknown
Registered
2019-03-29
Start date
2013-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The short duration of the follow&#45

Interventions

Patients in the experimental group received 50 mg/kg Magnesium sulfate 50% intravenous (diluted in 100 ml normal saline). Control group received 20 cc of normal saline (infused with the same volume as
Experimental Drug,Placebo Comparator Drug
magnesium ,normal saline

Sponsors

None listed

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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: 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 2.6 mg/dL); taking Calcium-channel blockers (CCBs), AV block degree II or III, systolic blood pressure 38 °C, history of heart disease, Liver failure, respiratory disease, renal failure, gastrointestinal bleeding, metabolic disorder, active peptic ulcer, and seizure.

Design outcomes

Primary

MeasureTime frame
pain 24-week Visual Analogue Scale (VAS)

Secondary

MeasureTime frame
quality of life 24-week Quality of life questionnaire

Countries

iran

Contacts

Public Contactbijan pirnia

Bijan Center for Substance Abuse Treatment, tehran, iran

b.pirnia@usc.ac.ir+9802122081450

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026