Pelvic and perineal pain
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled trial. A total of 120 people who meet the eligibility criteria will be allocated probabilistically to one or the other intervention group using a
Sponsors
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
Universidade Estadual de Campinas - UNICAMP/Campus Campinas
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| It is expected that in the group receiving the medication studied, compared to placebo, there will be a reduction in average pain during the insertion of the TCu380A Intrauterine Device (IUD) and the LNG 52 mg Intrauterine System (IUD) in the cervical clamping and hysterometry stages, with pain levels being obtained using an 11-point numerical scale (0 = no pain and 10 = severe pain);It is expected that in the group receiving the medication studied, compared to placebo, there will be a reduction in women's average perception of pain during the insertion procedure of the TCu380A Intrauterine Device (IUD) and LNG 52 mg Intrauterine System (IUD), assessed using a 4-point verbal descriptor scale, where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain;It is expected that the group receiving the medication studied will find it easier to insert the TCu380A Intrauterine Device (IUD) and LNG 52 mg Intrauterine System (IUD) by the doctor responsible for the procedure, compared to placebo, classified as: easy, moderate or difficult | — |
Countries
Brazil
Contacts
Public ContactLuis Bahamondes
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
Outcome results
None listed