Effectiveness of vaginal misoprostol and rectal nonsteroidal anti-inflammatory drug in vaginoscopic diagnostic outpatient hysteroscopy in primarily infertile women: Double-blind, randomized, controlled trial

摘要

Study Objective: To assess whether vaginally administered misoprostol or rectally administered nonsteroidal anti-inflammatory drug reduces pain during vaginoscopic diagnostic outpatient hysteroscopy in nulliparous infertile patients. Design: Double-blinded, randomized, controlled trial (Canadian Task Force classification I). Setting: Department of reproductive medicine at a university teaching hospital. Patients: One hundred fifty-eight primarily infertile women who underwent outpatient hysteroscopy for evaluation of infertility. Interventions: Patients were randomly assigned to 3 groups. Women in group 1 received 200μg misoprostol vaginally at 6hours before outpatient hysteroscopy and placebo tablets rectally at 60minutes before the procedure. Women in group 2 received placebo tablets rectally at 6hours before outpatient hysteroscopy and 100mg diclofenac sodium rectally at 60minutes before the procedure. Women in group 3 received placebo tablets vaginally at 6hours before outpatient hysteroscopy and placebo tablets rectally at 45 to 60minutes before the procedure. Patients were asked to record severity of pain, which was the primary outcome of the study, during the outpatient hysteroscopy procedure by using a visual analog scale ranging from 1 (very favorable) to 10 (very unfavorable). Secondary outcomes included procedural time from introduction of the hysteroscope through the external cervical os and visualization of the uterine cavity, patient acceptance recorded by the patient using a 5-point Likert scale, post-procedural analgesic requirements, and vasovagal effects. Measurements and Main Results: Median (range) pain scores for the women in group 1 (4.75 [3.12-6.54]) and group 2 (5.01 [2.8-7.05]) were not significantly different from those in group 3 (4.15 [2.17-6.92]) (p=.57). There was also no significant difference in patient acceptance (Likert scale) (p=.67), vasovagal symptoms (p=.84), procedure time (p=.05), and post-procedural analgesic requirement (p=.71). Conclusions: We were unable to demonstrate a benefit in pain reduction and patient acceptance with the use of vaginal misoprostol or rectal NSAIDs during vaginoscopic diagnostic outpatient hysteroscopy in nulliparous infertile women without a history of cervical stenosis. Trials investigating the optimal time for vaginal misoprostol premedication for pain relief in vaginoscopic outpatient hysteroscopy are needed. New interventions and/or drugs should be studied to decrease pain perception during vaginoscopic outpatient hysteroscopy.