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Effect of Pre-medication in Pain Measures on Office Hysteroscopy

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Hospital de Clinicas de Porto Alegre

关键词

抽象

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.

描述

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

日期

最后验证: 03/31/2018
首次提交: 04/12/2018
提交的预估入学人数: 04/12/2018
首次发布: 04/23/2018
上次提交的更新: 04/12/2018
最近更新发布: 04/23/2018
实际学习开始日期: 07/31/2017
预计主要完成日期: 12/30/2018
预计完成日期: 06/29/2019

状况或疾病

Pain

干预/治疗

Drug: Placebo Oral + Placebo Oral

Drug: Diclofenac oral + Placebo Oral

Drug: Diclofenac oral + scopolamina oral

相 4

手臂组

干预/治疗
Placebo Comparator: Placebo Oral + Placebo Oral
Placebo Oral + Placebo Oral
Drug: Placebo Oral + Placebo Oral
Placebo Oral + Placebo Oral
Active Comparator: Diclofenac oral + Placebo Oral
Diclofenac oral + Placebo Oral
Drug: Diclofenac oral + Placebo Oral
Diclofenac oral + Placebo Oral
Active Comparator: Diclofenac oral + scopolamina oral
Diclofenac oral + scopolamina oral
Drug: Diclofenac oral + scopolamina oral
Diclofenac oral + scopolamina oral

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别Female
接受健康志愿者
标准

Inclusion Criteria:

1. indication of intrauterine evaluation

2. Abnormal uterine bleeding

3. post-menopause uterine bleeding

4. infertility

5. recurrent miscarriage

Exclusion Criteria:

1. stenosis of the external cervical orifice,

2. pelvic inflammatory disease,

3. suspected gestation or pregnancy,

4. active bleeding at the time of examination

5. contraindication to the use of the study medication, diclofenac sodium and scopolamine,

结果

主要结果指标

1. Pain measure [until 1 hour after exam]

Pain Visual analogue score

次要成果指标

1. Likert scale [until 1 hour after exam]

Likert scale

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