Diclofenac versus a combination of hyoscine and diclofenac for outpatient hysteroscopy: A placebo controlled randomized clinical trial

Carlos Augusto Bastos de Souza, Vanessa Krebs Genro, Diego V. Tarrasconi, Maria Oppermann, João Sabino Cunha‐Filho
In: European Journal of Obstetrics & Gynecology and Reproductive Biology · 2020 · vol. 247 , pp. 1–5 · doi:10.1016/j.ejogrb.2020.01.030 · PMID:32044621 · W3000932746
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This randomized controlled trial compared diclofenac alone to a combination of hyoscine and diclofenac for outpatient hysteroscopy, assessing their efficacy.

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Abstract

Objectiveto compare the effect of administering diclofenac sodium and/or oral hyoscine in pain perception during and after outpatient diagnostic hysteroscopy without anesthesia.Study designa randomized, double-blind placebo-controlled clinical trial was performed in an University Hospital. We included 217 patients submitted to office hysteroscopy for the following indications: diagnosis of abnormal uterine bleeding, endometrial polyps, submucous myomas, infertility and recurrent miscarriage. Patients were allocated into 3 groups: (Group 1) placebo, (Group 2) diclofenac sodium 50 mg and (Group 3) diclofenac sodium 50 mg plus Hyoscine-N-Butylbromide 10 mg. The primary outcome was the visual analogue score immediately after the procedure. The secondary outcomes included Likert acceptance scale, the need for extra analgesia after the procedure, need to stay in the observation room and the occurrence of vagal symptoms.ResultsGroups were similar according to age, color, age of menarche, gravity, c-section, abortion, presence of pelvic pain, presence of uterine scar, height and body mass index. Patients in all three groups demonstrated similar visual pain scores when submitted to office hysteroscopy (Group 1: 4.18 ± 3.1, Group 2: 4.68 ± 2.9, group 3: 4.45 ± 2.9, P = 0.59). Moreover, patients presented high acceptance scores of the procedure, similar between groups. We performed a subgroup analysis in patients in treatment for chronic pelvic pain and, in this subgroup, prior medication with diclofenac sodium isolated or associated with hyoscine were both effective in decreasing pain levels when compared to placebo (Group 1: 6.0 ± 1.9, Group 2: 3.6 ± 2.1, group 3: 4.2 ± 1.5, P = 0.04).Conclusion(s)Office hysteroscopy is a well tolerated procedure and prior use of analgesic medication was not effective in decreasing pain. In selected patients with chronic pelvic pain the use prior analgesic medication may be beneficial.

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