Efficacy of Oral Paracetamol Compared with Oral Ketoprofen for Pain Management in Office Hysteroscopy: A Double-Blind, Randomized Clinical Trial.

Background and

Objectives

Hysteroscopy has become the "gold standard" in assessing uterine cavity abnormalities, and currently it can be performed in an "office setting". Although office hysteroscopy has a better level of comfort than operative hysteroscopy, pain is a common concern. Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used for pre-procedure analgesia, but they may cause gastrointestinal side effects. Paracetamol offers to be a safer alternative, but its efficacy in this setting is limited. This study aimed to compare the efficacy and safety of oral paracetamol with oral ketoprofen for pain management during office hysteroscopy. Materials and

Methods

Double-blind, parallel-group, randomized controlled trial conducted at a single hysteroscopy center in Jakarta, Indonesia, over a 2-year period. Sixty women undergoing office hysteroscopy were randomized (1:1) to receive paracetamol 1000 mg orally or ketoprofen 100 mg orally 1 h before the procedure.

Results

All participants completed the trial and were included in the analysis. The median visual analog score (VAS) during the procedure was 2 (range 0-8) in the paracetamol group versus 3 (range 0-6) in the ketoprofen group (p = 0.266). Median cramping scores 30 min post-procedure in the paracetamol group were 0 (range 0-5) vs. 0 (range 0-4) in the ketoprofen group, respectively (p = 0.499). Side effects occurred in 3 participants (10%) in the ketoprofen group and none of the paracetamol group. Comfort scores were high in both groups (median 9/10). No vagal reflexes were observed.

Conclusions

Oral 1000 mg paracetamol was as effective as oral 100 mg ketoprofen for pain management during and after office hysteroscopy, with fewer side effects. Paracetamol may be a safe and cost-effective alternative for pre-procedure analgesia in office hysteroscopy.