A randomized controlled trial of oral diclofenac potassium for analgesic control during office hysteroscopy

Office Hysteroscopy (OH) is a diagnostic gynecological procedure that enables the gynecologist to visualize the uterine cavity.There is no clear consensus within the literature as to the optimal method of pain relief during OH. Our objective was to investigate the effectiveness of oral diclofenac potassium in reducing the self-reported pain in patients undergoing OH. Double-blind randomized controlled trial (NCT02714699; clinicaltrials.gov) All eligible patients presenting for OH were approached for enrollment.Patients divided randomly and equally into 2 groups of 43 each: group (A) to receive 50 mg diclofenac potassium (cataflam) and group (B) to receive a placebo tablet. Tablets were taken under supervision of a study investigator orally 1 hour prior to OH.The primary outcome measure was the participant's self-rated pain perception using the 10-point Visual Analogue Scale (VAS) during the procedure.Secondary outcomes included the VAS score 30 minutes after OH, the subjective assessment of the ease of OH using a 10 cm scale, the post-procedure participants' satisfaction, the duration of OH and the adverse effects of the study medication. Wilcoxon rank-sum test was used to compare pain scores between groups. Chi square and Mann Whitney tests were used to assess factors associated with pain scores. No significant difference between both groups for age, BMI, parity and prior mode of delivery. VAS scores during OH was significantly less in diclofenac group than placebo group (median [IQR]: 3 [2-4] vs 5 [4-7], p=0.0001). However; no difference in VAS scores at 30 minutes post-procedure (median [IQR]: 1 [1-2] vs 1.5 [1-2], p=0.12). A higher ease of procedure score was also determined among diclofenac group (mean±SD: 7.2±1.15 vs 5.8±1.21, p=0.001). Additionally, women in the diclofenac group were more satisfied by the end of OH (86% vs. 69.7%, p=0.001). The mean duration of the procedure was significantly less in the diclofenac group (mean±SD: 5.23±1.59 vs 6.88±2.35 minutes, p=0.001). No adverse effects were reported. Administration of oral diclofenac potassium 1 hour prior to OH reduces the pain perception during the procedure with subsequent easier and shorter duration of OH.