A Randomized, Single Blind, Placebo-Controlled Trial for the Pain Reduction During the Outpatient Hysteroscopy After Ketoprofen or Intravaginal Misoprostol

Abstract

Study ObjectiveTo assess the efficacy of ketoprofen vs intravaginal misoprostol for pain relief during outpatient hysteroscopy. DesignProspective, randomized, single-blind, placebo-controlled clinical trial (Canadian Task Force classification I). SettingTertiary medical center. PatientsOne hundred fifty women referred for hysteroscopy between January and October 2013. InterventionsWomen were randomized to receive vaginal misoprostol, 400 μg, with 100 mL of 5% intravenous glucose (misoprostol arm); intravenous ketoprofen, 50 mg/mL, in 100 mL 5% glucose with intravaginal placebo (ketoprofen arm); or vaginal placebo tablets, 100 mL 5% intravenous glucose (placebo arm) before outpatient hysteroscopy. Measurements and Main ResultsA visual analog scale (VAS) was used for 1-dimensional pain assessment. Patients were asked to mark a VAS score before, during, and at 5 and 15 minutes after the procedure. Median VAS scores during and directly after the anesthesia-free hysteroscopy were significantly lower in the misoprostol group than in the ketoprofen (p = .02) or placebo (p = .006) groups. There were no statistical differences between the 3 arms in median VAS score assessed at 15 minutes after the procedure (p = .16). There were no differences in procedure time between groups (p = .16). ConclusionWhen administrated 4 hours before the procedure, 400 μg vaginal misoprostol seems to reduce the pain during and immediately after hysteroscopy. The effect does not depend on patient age, hormone status, parity, or type of outpatient hysteroscopy (operative or diagnostic).