Effect of Pre-medication in Pain Measures on Office Hysteroscopy

NCT03506763 | Unknown Phase 4

• 1 other identifier: 65409017.0.0000.5327
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

office hysteroscopy, pain measure

Outcome Measures

Primary Outcomes (1)

• Pain measure

  Pain Visual analogue score

  until 1 hour after exam

Secondary Outcomes (1)

• Likert scale

  until 1 hour after exam

Study Arms (3)

Placebo Oral + Placebo Oral

PLACEBO COMPARATOR

Placebo Oral + Placebo Oral

Drug: Placebo Oral + Placebo Oral

Diclofenac oral + Placebo Oral

ACTIVE COMPARATOR

Diclofenac oral + Placebo Oral

Drug: Diclofenac oral + Placebo Oral

Diclofenac oral + scopolamina oral

ACTIVE COMPARATOR

Diclofenac oral + scopolamina oral

Drug: Diclofenac oral + scopolamina oral

Interventions

Placebo Oral + Placebo Oral DRUG

Placebo Oral + Placebo Oral

Also known as: Placebo

Placebo Oral + Placebo Oral

Diclofenac oral + Placebo Oral DRUG

Diclofenac oral + Placebo Oral

Also known as: Diclofenac 50 mg oral tablet

Diclofenac oral + Placebo Oral

Diclofenac oral + scopolamina oral DRUG

Diclofenac oral + scopolamina oral

Also known as: Diclofenac 50 mg oral tablet, scopolamin 10 mg oral tablet

Diclofenac oral + scopolamina oral

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication of intrauterine evaluation
• Abnormal uterine bleeding
• post-menopause uterine bleeding
• infertility
• recurrent miscarriage

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Diclofenac; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Joao Sabino, MD

  HCPA- Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos A Souza, MD

CONTACT

+5551981189937; cbsouza@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: RCT, blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 24, 2018
• Study Start: August 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

BR (1)