MedTrace Logo

Effect of Pre-medication in Pain Measures on Office Hysteroscopy

NCT03506763 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2018-04-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo Oral + Placebo Oral

Placebo Oral + Placebo Oral

DRUG

Diclofenac oral + Placebo Oral

Diclofenac oral + Placebo Oral

DRUG

Diclofenac oral + scopolamina oral

Diclofenac oral + scopolamina oral

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Joao Sabino, MD · HCPA- Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-12-31
Completion
2019-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03506763 on ClinicalTrials.gov