Effect of Pre-medication in Pain Measures on Office Hysteroscopy

Phase 4

• Conditions: Pain
• Interventions: Drug: Placebo Oral + Placebo Oral; Drug: Diclofenac oral + scopolamina oral; Drug: Diclofenac oral + Placebo Oral

• Registration Number: NCT03506763
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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

Study Timeline

• Study Start: 2017-08-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-13
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-24
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 231

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo Oral + Placebo Oral	Placebo Oral + Placebo Oral	Placebo Oral + Placebo Oral
Diclofenac oral + scopolamina oral	Diclofenac oral + scopolamina oral	Diclofenac oral + scopolamina oral
Diclofenac oral + Placebo Oral	Diclofenac oral + Placebo Oral	Diclofenac oral + Placebo Oral

Primary Outcome Measures

Name	Time	Method
Pain measure	until 1 hour after exam	Pain Visual analogue score

Secondary Outcome Measures

Name	Time	Method
Likert scale	until 1 hour after exam	Likert scale

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil