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

Carlos A B Souza, Carlos Augusto Bastos de Souza, Vanessa Krebs Genro, Vanessa K Genro, Diego V. Tarrasconi, Maria L R Oppermann, Maria Oppermann, João S L Cunha Filho, João Sabino Cunha‐Filho
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

OBJECTIVE: to compare the effect of administering diclofenac sodium and/or oral hyoscine in pain perception during and after outpatient diagnostic hysteroscopy without anesthesia. STUDY DESIGN: a 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. RESULTS: Groups 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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MeSH descriptors

Analgesics Butylscopolammonium Bromide Diclofenac Hysteroscopy Pain Management Administration, Oral Adult Analgesics Butylscopolammonium Bromide Diclofenac Double-Blind Method Drug Therapy, Combination Female Humans Hysteroscopy Middle Aged Pain Management Pain Measurement Pain Measurement Preoperative Period

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