Efficacy of analgesics in controlling pain associated with the insertion of a Copper or Hormone Intrauterine Device
- Conditions
- Pelvic and perineal painInsertion of contraceptive device (intrauterine)R52.0
- Registration Number
- RBR-7phn8yv
- Lead Sponsor
- Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Women; with ability to confirm voluntary participation and agree to all the purposes of the trial by signing and dating the Informed Consent Form; age between 18 and 49; participants who will undergo the TCu380A Intrauterine Device (IUD) or LNG 52mg Intrauterine Device (IUD) insertion procedure for the first time; nulliparous women
Any clinical observation finding (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the research participant's participation in the clinical trial or presence of uncontrolled chronic disease; chronic pelvic pain of any etiology; abnormality in the uterine cavity; psychiatric disorders; chronic use of medications that interfere with the pain threshold, e.g.: antidepressants and anticonvulsants; use of analgesics and/or anti-inflammatory drugs in the last 24 hours before the procedure; signs and/or symptoms of vaginal and/or cervical infection; contraindication to the use of Trometamol Ketorolac 10 mg, or Dipyrone Monohydrate + Scopolamine Butylbromide + Hyoscyamine Hydrobromide + Homatropine Methylbromide, 300 mg + 6.5 mcg + 104 mcg + 1mg; current alcohol or illicit drug use disorder; breastfeeding; participants with known allergy or hypersensitivity to the components of the drugs; participants with a current medical history of cancer and/or treatment for cancer in the last 5 years; participated in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, sub-item J), unless the investigator judges that there may be a direct benefit to the investigator
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to find in the group receiving the medication studied, compared to placebo, a reduction in the average pain at the time of insertion of the Intrauterine Device (IUD) TCu380A and Intrauterine System (IUD) LNG 52 mg, the average overall pain related to the procedure and the average pain reported 10 minutes after the end of the procedure, with pain levels being obtained using an 11-point numerical scale (0 = no pain and 10 = severe pain)
- Secondary Outcome Measures
Name Time Method