title: Effectiveness of vaginal misoprostol and rectal nonsteroidal anti-inflammatory drug in vaginoscopic diagnostic outpatient hysteroscopy in primarily infertile women: double-blind, randomized, controlled trial.
abstract: 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.
  
  
  METHODS
  Double-blinded, randomized, controlled trial (Canadian Task Force classification I).
  
  
  METHODS
  Department of reproductive medicine at a university teaching hospital.
  
  
  METHODS
  One hundred fifty-eight primarily infertile women who underwent outpatient hysteroscopy for evaluation of infertility.
  
  
  METHODS
  Patients were randomly assigned to 3 groups. Women in group 1 received 200 μg misoprostol vaginally at 6 hours before outpatient hysteroscopy and placebo tablets rectally at 60 minutes before the procedure. Women in group 2 received placebo tablets rectally at 6 hours before outpatient hysteroscopy and 100 mg diclofenac sodium rectally at 60 minutes before the procedure. Women in group 3 received placebo tablets vaginally at 6 hours before outpatient hysteroscopy and placebo tablets rectally at 45 to 60 minutes 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.
  
  
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Eskisehir Osmangazi University School of Medicine, Eskisehir, Turkey.
authors.forename: Hikmet
authors.initials: H
authors.lastname: Hassa
authors.forename: Yunus
authors.initials: Y
authors.lastname: Aydin
authors.forename: Tufan
authors.initials: T
authors.lastname: Oge
authors.forename: Kiymet
authors.initials: K
authors.lastname: Cicek
mesh_terms: D000282:Administration, Intravaginal; D000285:Administration, Rectal; D000328:Adult; D000698:Analgesia / Q000379:methods*; D000700:Analgesics / Q000008:administration & dosage / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015907:Hysteroscopy / Q000379:methods*; D007247:Infertility, Female / Q000175:diagnosis*; D016595:Misoprostol / Q000008:administration & dosage / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011247:Pregnancy; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D016595:Misoprostol
keywords: Misoprostol; Nonsteroidal anti-inflammatory drug; Outpatient hysteroscopy; Visual analog scale