Oral Diclofenac Potassium Versus Hyoscine-N-Butyl Bromide in Reducing Pain Perception during Office Hysteroscopy: ARandomized Double-blind Placebo-controlled Trial

Abstract

To compare the efficacy of oral diclofenac potassium versus hyoscine-N-butyl bromide (HBB) in reducing pain perception in patients undergoing diagnostic office hysteroscopy (OH). A randomized double-blind placebo-controlled trial (Canadian Task Force classification I). A university hospital. One-hundred twenty-nine patients were divided randomly into 3 groups (n = 43 in each group); group 1 received 50mg diclofenac potassium, group 2 received 20mg HBB, and group 3 received placebo tablets. All tablets were taken orally 1hour before OH. The primary outcome was the participant's self-rated pain perception using the 10-point visual analog scale during the procedure. The secondary outcomes included the visual analog scale score 30 minutes after OH, ease of OH assessment using a 10-cm scale, duration of OH, and adverse effects of the study medications. Both the diclofenac and HBB groups showed significant pain score reduction compared with the placebo group (p = .001). The mean pain score in the diclofenac group was significantly lower than the HBB group (2.12 ± 1.03vs 3.02 ± 1.55, respectively; p = .002). The pain scores in the diclofenac and HBB groups immediately after OH were significantly lower than the placebo group (p = .001), and the mean pain score in the diclofenac group was significantly lower than the HBB group (1.23 ± 0.57vs 1.56 ± 0.73, respectively; p = .024). The ease of procedure score was significantly lower in the diclofenac and HBB groups than the placebo group (p = .003 and p = .005, respectively). The mean duration of the procedure was significantly less in the diclofenac group (p = .01). Fourteen women (32.6%) in the HBB group experienced dizziness and 2 women (4.6%) had nausea, whereas only 4 women (9.3%) in the diclofenac group had dizziness and 2 women (4.6%) had vomiting. Oral diclofenac potassium administration 1hour before diagnostic OH reduces the procedure pain with subsequent easier and shorter OH duration. Oral HBB is less effective than diclofenac potassium with more adverse effects.