A Study to Investigate the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy

ConditionPain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorASST Fatebenefratelli Sacco

About this trial

For outpatient hysteroscopy (OH), it is recommended to take a standard dose of NSAIDs or more hyoscine-n butyl bromide (HBB) an hour prior to the procedure to minimize pain during the first postoperative hour. As there is currently no clear consensus in the literature regarding the best approach to pain management associated with office hysteroscopy procedures. This Phase 4 study is being conducted to evaluate the effectiveness of oral ibuprofen alone and in combination with HBB to determine the most appropriate strategy for improving pain perception in outpatients.

Eligibility criteria

Qualifiers

female patients older than 18 years who signed informed consent;

patients who need an office hysteroscopy for their diagnosis or treatment. Those indications included postmenopausal endometrial thickening (over 4 mm), metrorrhagia, sonographic suspicion of endometrial polyps or myomas, Essure device insertion, and endometrial biopsy

Disqualifiers

women with a possible pregnancy, ongoing vaginal bleeding, lower genital tract infection, gestational trophoblastic disease, asthma, hepatitis, renal failure, lactation, previous cervical surgery, or oversensitivity to one of the agents or their elements;

patients suffering from neuropathic pain or other conditions that can impact on the perception of pain;

individuals who use antidepressant, anxiolytics or other drugs/supplements that may have an impact on the perception of pain;

contraindications to the use of ibuprofen and/or Hyoscine N-Butil Bromide .

Trial design

Treatments tested in this trial

  • Ibuprofen 400 mg
  • Hyoscine N-Butil Bromide
  • placebo

Treatment groups

190 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators