Efficacy and safety of Tramadol as an analgesic in women undergoing vaginoscopic hysteroscopy: a randomized placebo-controlled trial.

Abstract

Pain or discomfort during the hysteroscopy remains a challenge even after the introduction of small calibre instruments and vaginoscopic techniques. Tramadol, a centrally acting analgesic, is one among the medications used to reduce pain; however, the experience with its use in the vaginoscopic technique is limited. This was a randomised double-blind placebo-controlled trial conducted to study the effectiveness of oral Tramadol as an analgesic in 100 women undergoing diagnostic vaginoscopic hysteroscopy. Median pain score assessed by the Visual Analogue Scale was lower in the study group compared to the placebo group during the procedure (7 versus 8; p < .001) and immediately after the procedure (6 versus 7; p < .001) Ease of entry, procedure entry time and the adverse effects were similar in both the groups. Administration of oral Tramadol 50 mg, 1 h prior to the procedure may be a safe and effective analgesic in women undergoing diagnostic vaginoscopic hysteroscopy.Impact statementWhat is already known on this subject? Even with the use of newer hysteroscopes with small calibres and vaginoscopic techniques, pain and discomfort to the patient during negotiation through the cervix remain the main challenge to the surgeon. Among the several medications reported to reduce pain during the procedure, Tramadol a centrally acting drug with dual analgesic action, both by the µ opioid receptor agonist action and by the inhibiting uptake of serotonin and norepinephrine, can be used. However, studies using oral Tramadol during vaginoscopic hysteroscopy are limited.What do the results of this study add? The median pain score assessed by the Visual Analogue Scale was lower in the study group compared to the placebo group during the procedure (7 versus 8; p < .001) and immediately after the procedure (6 versus 7; p < .001). Ease of entry, procedure entry time and the adverse effects were similar in both the groups.What are the implications of these findings for clinical practice and/or further research? This study suggests that administration of oral Tramadol 50 mg, 1 h prior to the procedure, may be used as a safe and effective analgesic in women undergoing diagnostic vaginoscopic hysteroscopy. Future trial with a larger sample size is required to confirm the tolerability of its use, as the incidence of adverse effects was low in the study.