RESUMEN
OBJECTIVE: To evaluate whether a 12-mL paracervical block is noninferior to a 20-mL block in reducing pain with osmotic dilator insertion. METHODS: In this single-blinded noninferiority trial, we randomized individuals undergoing insertion of osmotic dilators before second-trimester abortion to receive either a 12-mL or 20-mL 1% lidocaine paracervical block. The primary outcome was pain immediately after insertion of osmotic dilators. Prespecified secondary outcomes included pain with paracervical block administration, overall pain, and side effects, with 88 participants being required for a noninferiority margin of 15 mm on a 100-mm visual analog scale assuming an SD of 28. We analyzed data using Wilcoxon rank sum, χ2, and t tests and performed analysis of variance to account for repeated measures. Secondary analysis included multivariable regression to explore potential confounders. RESULTS: From January 2018 to October 2020, of 232 eligible individuals, 174 were approached and 96 randomized (48 participants to each group); 91 were available for analysis (45: 12 mL, 46: 20 mL). Group demographics were similar, with a mean gestation of 21 weeks and four osmotic dilators placed. The 12-mL paracervical block was noninferior to the 20-mL paracervical block for pain with osmotic dilator insertion with a difference in means of -1.36 (95% CI -12.56 to 9.85) favoring 12 mL. Median pain scores after dilator placement were 47 mm (interquartile range 22-68) and 50 mm (interquartile range 27-67) in 12-mL compared with 20-mL paracervical block, respectively (P=.81). No difference was seen in median pain at baseline, with paracervical block administration, postprocedure or with overall pain or experience. At least one lidocaine-related side effect occurred in 4% of participants in the 12-mL group compared with 13% for those receiving 20 mL (P=.15), with metallic taste, ringing in ears, and lightheadedness being most common. CONCLUSION: A 12-mL paracervical block is noninferior to a 20-mL block for pain reduction with osmotic dilator insertion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03356145.
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Aborto Inducido , Anestésicos Locales/administración & dosificación , Lidocaína/administración & dosificación , Dolor/prevención & control , Atención Prenatal , Adulto , Cuello del Útero , Femenino , Humanos , Dimensión del Dolor , Embarazo , Segundo Trimestre del Embarazo , Método Simple Ciego , Resultado del TratamientoRESUMEN
BACKGROUND: A major barrier to intrauterine device use is fear of pain during insertion. Trials exploring analgesic interventions for intrauterine device insertion have yielded mixed results, and no standardized pain management guidelines currently exist for this procedure. In an abortion-related study, self-administered lidocaine gel over a prolonged time interval showed promise as a method of pain control. OBJECTIVE(S): The objective of the study was to assess pain control with intrauterine device insertion after patient-administered lidocaine gel compared with placebo. STUDY DESIGN: We conducted a randomized, blinded trial of women undergoing levonorgestrel or copper intrauterine device insertion in an outpatient gynecology clinic between July 2016 and April 2017. Participants self-administered either 20 mL of 2% lidocaine gel or placebo gel vaginally at least 15 minutes prior to intrauterine device insertion. No other analgesics were administered. The primary outcome was pain during intrauterine device insertion, measured on a 100-mm visual analog scale (0 being no pain and 100 being worst pain imaginable). Secondary outcomes included anticipated and baseline pain and pain with speculum insertion and tenaculum placement. In a postprocedure questionnaire, participants reported acceptability of vaginal gel and willingness to wait for pain control. Median values were assessed because of the nonnormal distribution of visual analog scale scores using the Mann-Whitney U test. Predictors of intrauterine device insertion pain were assessed using a multiple linear regression. RESULTS: In total, 220 women were randomized and 215 were included in analysis (108 in lidocaine gel, 107 in placebo gel groups). Median (range) time from gel administration to speculum insertion was 21 (14-74) and 20 (12-43) minutes in the lidocaine and placebo groups, respectively (P = .13). The median pain scores during intrauterine device insertion were not significantly different: 65 (1-99) mm in the lidocaine group and 59 (5-100) mm in the placebo group (P = .09). Among secondary outcome time points, only median pain scores at speculum insertion were significantly different between the lidocaine and placebo groups (7 [0-81] mm vs 11 [0-80] mm, respectively; P = .046). Anticipated pain and menstrual pain were both predictors of pain with intrauterine device insertion. The majority of women in both groups found the amount of vaginal leakage following gel insertion to be acceptable (>80%). Ninety-two percent of participants (n = 194) stated they would be willing to wait before intrauterine device placement for a potential analgesic effect. CONCLUSION: Self-administered lidocaine gel at least 15 minutes before intrauterine device insertion does not appear to reduce pain compared with placebo but may help with speculum insertion. We found that women are willing to extend visit time to gain pain control. Self-administration of local anesthetic is acceptable to patients and should be considered in future research.
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Anestésicos Locales/administración & dosificación , Dispositivos Intrauterinos Medicados/efectos adversos , Lidocaína/administración & dosificación , Dolor Asociado a Procedimientos Médicos/prevención & control , Adolescente , Adulto , Anestésicos Locales/uso terapéutico , Anticonceptivos Femeninos/administración & dosificación , Método Doble Ciego , Femenino , Humanos , Levonorgestrel/administración & dosificación , Lidocaína/uso terapéutico , Persona de Mediana Edad , Dimensión del Dolor , Dolor Asociado a Procedimientos Médicos/diagnóstico , Resultado del Tratamiento , Cremas, Espumas y Geles Vaginales , Adulto JovenRESUMEN
BACKGROUND: Sexual and gender minority (SGM) individuals experience high rates of harassment and discrimination when seeking healthcare, which contributes to substantial healthcare disparities. Improving physician training about gender identity, sexual orientation, and the healthcare needs of SGM patients has been identified as a critical strategy for mitigating these disparities. In 2014, the Association of American Medical Colleges (AAMC) published medical education competencies to guide undergraduate medical education on SGM topics. OBJECTIVE: Conduct pilot study to investigate medical student comfort and competence about SGM health competencies outlined by the AAMC and evaluate curricular coverage of SGM topics. DESIGN: Six-hundred and fifty-eight students at New England allopathic medical schools (response rate 21.2%) completed an anonymous, online survey evaluating self-reported comfort and competence regarding SGM health competencies, and coverage of SGM health in the medical curriculum. RESULTS: 92.7% of students felt somewhat or very comfortable treating sexual minorities; 68.4% felt comfortable treating gender minorities. Most respondents felt not competent or somewhat not competent with medical treatment of gender minority patients (76.7%) and patients with a difference of sex development (81%). At seven schools, more than 50% of students indicated that the curriculum neither adequately covers SGM-specific topics nor adequately prepares students to serve SGM patients. CONCLUSIONS: The prevalence of self-reported comfort is greater than that of self-reported competence serving SGM patients in a convenience sample of New England allopathic medical students. The majority of participants reported insufficient curricular preparation to achieve the competencies necessary to care for SGM patients. This multi-institution pilot study provides preliminary evidence that further curriculum development may be needed to enable medical students to achieve core competencies in SGM health, as defined by AAMC. Further mixed methods research is necessary to substantiate and expand upon the findings of this pilot study. This pilot study also demonstrates the importance of creating specific evaluation tools to assess medical student achievement of competencies established by the AAMC.
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Actitud del Personal de Salud , Competencia Clínica , Educación de Pregrado en Medicina/normas , Minorías Sexuales y de Género , Estudiantes de Medicina/psicología , Curriculum , Identidad de Género , Humanos , New England , Percepción , Proyectos Piloto , Factores Sexuales , Factores SocioeconómicosRESUMEN
OBJECTIVE: To assess user satisfaction and acceptability toward a cell phone-based short message system (SMS) application for fertility awareness. METHODS: Between July 1 and September 30, 2013, the present observational study recruited women of reproductive age who were presenting for family planning services in Lucknow, India, who were not pregnant, agreed to use the application, and understood basic English. The application collected information on an individual's menstrual cycle and, using the calendar days approach, predicted fertility. Based on an algorithm, the application sent a daily SMS text indicating the participant's fertility status. Participants completed an acceptability survey at the end of the 60-day pilot period. RESULTS: There were 21 participants enrolled. All reported that the application was highly acceptable, and found it to be private, secure, and convenient. All participants were interested in receiving future SMS reminders for tracking fertility. Most participants (20 [95%]) reported being likely or very likely to recommend the family planning application to friends. CONCLUSION: The application, with the aims of helping participants to identify their most fertile days once a month during ovulation and make informed decisions regarding fertility and contraception, was highly acceptable and might be useful in low-resource settings worldwide. Larger studies are needed for software optimization and determination of long-term effectiveness.