Effect of Pre-medication in Pain Measures on Office Hysteroscopy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506763
• Other study ID #: 65409017.0.0000.5327
• Status: Recruiting
• Phase: Phase 4
• First received: April 13, 2018
• Last updated: April 13, 2018
• Start date: August 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Carlos A Souza, MD
• Phone: +5551981189937
• Email: cbsouza[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 231
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo Oral + Placebo Oral
Placebo Oral + Placebo Oral
• Diclofenac oral + Placebo Oral
Diclofenac oral + Placebo Oral
• Diclofenac oral + scopolamina oral
Diclofenac oral + scopolamina oral

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measure	Pain Visual analogue score	until 1 hour after exam
Secondary	Likert scale	Likert scale	until 1 hour after exam