Pain
Conditions
Keywords
hysteroscopy
Brief summary
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.
Detailed description
This is a randomized, phase IV, double-blind, placebo-controlled clinical trial. The subjects will be randomly assigned into one of two treatment arms: * Group A (Ibuprofen ): will receive one tablet of ibuprofen 400 mg and two tablets of placebo (similar in size, structure and colour to HBB) * Group B (Ibuprofen plus HHB): will assume one tablet of ibuprofen 400 mg plus two tablets of HHB 10 mg. The purpose of this study is 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.
Interventions
DRUGIbuprofen 400 mg
Ibuprofen 400 mg tablet
DRUGHyoscine N-Butil Bromide
Hyoscine N-Butil Bromide 10 mg two tablets
DRUGplacebo
Two tablets
Sponsors
ASST Fatebenefratelli Sacco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Upon confirmation of eligibility, subjects will be randomly assigned (with a 1:1 allocation as per a computer generated randomization list with the same number of patients in each group) into one of two treatment arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) | During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure | The primary objective of this study is to determine the effectiveness of the use of ibuprofen 400 mg alone or a combination of 400 mg ibuprofen and 20 mg Hyoscine N-Butil Bromide, one hour before office hysteroscopy, has a different impact on reducing pain in patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog pain score for pain assessment (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) | During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure | To assess a different response to analgesic treatment between nullipare and multipare |
| Use of Visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) | 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure | To evaluate response in post menopausal condition |
| Measure of the level of anxiety (through STAI-Y1 items, with a score from 1 to 4, where: 1 = not at all and 4 = very much) | During office hysteroscopy | Measure of the level of pre-procedural anxiety through the STAI-Y (scoring range: 20-80; cut-off: 39-40) |
| Rate of adverse effects (percentage of events collected) | up to 24 hours | Determine the safety profile of the study medications |
Contacts
Primary ContactLorenzo Quirino
Outcome results
None listed