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Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure.
Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality.
Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2 placebo tablets.
Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.
Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.
Pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). Acceptance of the procedure and assessed through the Likert 5-point scale: 1) totally disagree; 2) disagree; 3) I do not agree or disagree; 4) I agree and 5) I totally agree.There will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Oral + Placebo Oral | Placebo Comparator | Placebo Oral + Placebo Oral |
|
| Diclofenac oral + Placebo Oral | Active Comparator | Diclofenac oral + Placebo Oral |
|
| Diclofenac oral + scopolamina oral | Active Comparator | Diclofenac oral + scopolamina oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral + Placebo Oral | Drug | Placebo Oral + Placebo Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain measure | Pain Visual analogue score | until 1 hour after exam |
| Measure | Description | Time Frame |
|---|---|---|
| Likert scale | Likert scale | until 1 hour after exam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos A Souza, MD | Contact | +5551981189937 | cbsouza@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Joao Sabino, MD | HCPA- Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035003 | Brazil |
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| 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 |
|---|---|
| D004008 | Diclofenac |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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RCT
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RCT, blind
| Diclofenac oral + Placebo Oral | Drug | Diclofenac oral + Placebo Oral |
|
|
| Diclofenac oral + scopolamina oral | Drug | Diclofenac oral + scopolamina oral |
|
|
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |