Abstract
BackgroundTo compare the effectiveness of 550 mg naproxen sodium versus 6 mL 2%-lidocaine intracervical block in pain lowering at the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) placement in young women.MethodsIn this randomized controlled trial, 100 women aged 15–24 years were block-randomized to receive either 6 mL 2%-lidocaine intracervical block 5 min before the LNG-IUS insertion or 550 mg naproxen 30 min before the procedure. Forty-nine women received 550 mg naproxen and 51 received intracervical block. The primary outcome was pain at LNG-IUS insertion. Secondary outcomes were ease of insertion, insertion failures, and correct IUS positioning. Neither participants nor doctors were blinded. Pain at insertion was assessed by using a Visual Analog Scale (VAS).ResultsWomen randomized to lidocaine intracervical block presented lower mean pain score at insertion, when compared to women who received naproxen (5.4 vs. 7.3, respectively; p < 0.001). Parous women had a 90.1% lower chance of experiencing severe pain (p = 0.004). There was a 49.8% reduction in the chance of severe pain for every 1-cm increase in the hysterometry (p = 0.002). The only complication observed during insertion was vasovagal-like reactions (7%). The insertion was performed without difficulty in 82% of the women. Participants in the intracervical block group presented higher proportion of malpositioned IUS on transvaginal ultrasound examination compared to women in naproxen group. Nevertheless, all the malpositioned IUS were inserted by resident physicians.ConclusionLidocaine intracervical block was found to be more effective than naproxen in reducing LNG-IUS insertion pain.Trial registration number: RBR-68mmbp, Brazilian Registry of Clinical Trials, Retrospectively registered (August 4, 2020), URL of trial registry record: https://ensaiosclinicos.gov.br/rg/RBR-68mmbp/.
Highlights
To compare the effectiveness of 550 mg naproxen sodium versus 6 mL 2%-lidocaine intracervical block in pain lowering at the 52-mg levonorgestrel-releasing intrauterine system (LNG-Intrauterine system (IUS)) placement in young women
All women who agreed to participate in the study signed an Informed Consent Form (ICF)
The study included nulliparous or parous women aged 15–24 years who were eligible for the levonorgestrel-releasing intrauterine system (LNG-IUS) use, according to the World Health Organization (WHO) medical eligibility criteria for contraceptive use
Summary
To compare the effectiveness of 550 mg naproxen sodium versus 6 mL 2%-lidocaine intracervical block in pain lowering at the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) placement in young women. Increased utilization of long-acting reversible contraceptive (LARC) methods is an important strategy to reduce unintended pregnancy rates, as LARC have higher efficacy, higher continuation rates, and higher satisfaction rates compared with short-acting contraceptives [3, 4]. The US‐based Contraceptive CHOICE Project found LARC methods to be 20 times more effective than non-LARC methods, resulting in substantial reductions in teen pregnancy, birth, and abortion compared with national rates [4]. Both the American College of Gynecology and Obstetrics (ACOG) and the American Academy of Pediatrics (AAP) recommend LARC methods as the first-line contraceptive choice for preventing teenage pregnancy [6,7,8,9]
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