Effect of Pre-medication in Pain Measures on Office Hysteroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Pre-medication in Pain Measures on Office Hysteroscopy - Randomized Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Placebo Oral + Placebo Oral
* Drug: Diclofenac oral + Placebo Oral
* Drug: Diclofenac oral + scopolamina oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication of intrauterine evaluation Abnormal uterine bleeding post-menopause uterine bleeding infertility recurrent miscarriage Exclusion Criteria: stenosis of the external cervical orifice, pelvic inflammatory disease, suspected gestation or pregnancy, active bleeding at the time of examination contraindication to the use of the study medication, diclofenac sodium and scopolamine,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: RCT
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Oral + Placebo Oral<br>Placebo Oral + Placebo Oral | Drug: Placebo Oral + Placebo Oral<br>* Placebo Oral + Placebo Oral<br>* Other names: Placebo;|
| Active Comparator: Diclofenac oral + Placebo Oral<br>Diclofenac oral + Placebo Oral | Drug: Diclofenac oral + Placebo Oral<br>* Diclofenac oral + Placebo Oral<br>* Other names: Diclofenac 50 mg oral tablet;|
| Active Comparator: Diclofenac oral + scopolamina oral<br>Diclofenac oral + scopolamina oral | Drug: Diclofenac oral + scopolamina oral<br>* Diclofenac oral + scopolamina oral<br>* Other names: Diclofenac 50 mg oral tablet, scopolamin 10 mg oral tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measure | Pain Visual analogue score | until 1 hour after exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert scale | Likert scale | until 1 hour after exam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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office hysteroscopy, pain measure