Insertion of (intrauterine) contraceptive device
Conditions
Interventions
In this randomized controlled trial, 100 women aged 15-24 years were block-randomized to receive 6mL 2%-lidocaine intracervical block or 550 mg naproxen 30 minutes before the 52mg LNG-IUS insertion. F
Drug
Device
Sponsors
Faculdade de Medicina-Universidade Federal de Minas Gerais
Faculdade de Medicina-Universidade Federal de Minas Gerais
Eligibility
Sex/Gender
Female
Age
15 Years to 24 Years
Inclusion criteria
Inclusion criteria: The study included 100 healthy nulligravous women, aged 15-24 years, with indications for use of SIU-LNG (contraception, discontinuation of menstruation, control of menorrhagia, dysmenorrhea, etc.).
Exclusion criteria
Exclusion criteria: The study excluded patients with: hysterometry less than 5 cm; cytological changes in cytology of the last eighteen months; known distortion of the uterine cavity (e.g., by submucosal fibroids); contraindications to the use of progestins; recent history of pelvic inflammatory disease or untreated genitourinary tract infection; abnormal uterine bleeding of unknown cause; less than 6 weeks postpartum or postabortion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: To evaluate what is the best method for pain relief during insertion of the levonorgestrel-releasing intrauterine system in young patients: cervical block with lidocaine or naproxen (randomized clinical trial).;Outcome found 1: Regarding Pain (VAS), the result shows that there is a statistically significant difference (p lower than 0.001, therefore, p lower than 0.05) between the 2 pain relief methods, where, on average, the pain scale of the treated patients by the Naproxen method (Mean equal 7.3) is significantly higher than in patients treated by the Block method (Mean equal 5.4). The same conclusion is reached when the scale is grouped into the degree of pain (Absent / Mild, Moderate and Intense), that is, there is a statistically significant association (p equal 0.008, that is, p lower than 0.05) between the method used and the degree of pain, where, the pain is significantly greater in the group of patients treated by the Naproxen method.;Expected outcome 2: Assess the degree of satisfaction and maintenance rate of the method for 6 and 12 months, as well as its rate of discontinuation. ;Outcome found 2: The results show that there is no statistically significant difference between the 2 pain relief methods, that is, the proportion of patients satisfied with the SIU-LNG treated by the Naproxen Method is similar to the proportion of patients treated by the Blocking method. Most patients are satisfied with the use of SIU-LNG at 3, 6 and 12 months of use, with satisfaction rates of 95.7, 96.3 and 93.9 percent respectively. Most SIU-LNG were removed until the first 6 months of use (9 withdrawals). Regarding the withdrawal / expulsion or not of the SIU-LNG, the results show that, in relation to the 6 and 12 months of follow-up, there is a statistically significant association between the pain relief method applied to patients and the withdrawal / expulsion of the SIU, where, in both phases, the patients in the group treated by the Block method h | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactAna Lunardi
Faculdade de Medicina-Universidade Federal de Minas Gerais
Outcome results
None listed