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

OBJECTIVE

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).

METHODS

A randomized double-blind placebo-controlled trial (Canadian Task Force classification I).

METHODS

A university hospital.

METHODS

One-hundred twenty-nine patients were divided randomly into 3 groups (n = 43 in each group); group 1 received 50 mg diclofenac potassium, group 2 received 20 mg HBB, and group 3 received placebo tablets. All tablets were taken orally 1 hour 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.

RESULTS

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 ± 1.03 vs 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 ± 0.57 vs 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.

CONCLUSIONS

Oral diclofenac potassium administration 1 hour 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.