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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.
This is a randomized, phase IV, double-blind, placebo-controlled clinical trial.
The subjects will be randomly assigned into one of two treatment arms:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Placebo Comparator | will receive one tablet of ibuprofen 400 mg and two tablets of placebo (similar in size, structure and colour to Hyoscine N-Butil Bromide) |
|
| Ibuprofen plus HHB | Experimental | will assume one tablet of ibuprofen 400 mg plus two tablets of Hyoscine N-Butil Bromid 10 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 400 mg | Drug | Ibuprofen 400 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) | 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. | During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog pain score for pain assessment (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) | To assess a different response to analgesic treatment between nullipare and multipare | During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Quirino | Contact | 02. 63632349 | lorenzo.quirino@asst-fbf-sacco.it |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Quirino | ASST Fatebenefratelli Sacco | Principal Investigator |
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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
| Hyoscine N-Butil Bromide |
| Drug |
Hyoscine N-Butil Bromide 10 mg two tablets |
|
| placebo | Drug | Two tablets |
|
| Use of Visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain) |
To evaluate response in post menopausal condition |
| 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure |
| 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) | Measure of the level of pre-procedural anxiety through the STAI-Y (scoring range: 20-80; cut-off: 39-40) | During office hysteroscopy |
| Rate of adverse effects (percentage of events collected) | Determine the safety profile of the study medications | up to 24 hours |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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