Effect of Pre-medication in Pain Measures on Office Hysteroscopy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03506763

Enrollment

231

Registered

2018-04-24

Start date

2017-08-01

Completion date

2019-06-30

Last updated

2018-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

office hysteroscopy, pain measure

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

Interventions

DRUGPlacebo Oral + Placebo Oral

Placebo Oral + Placebo Oral

DRUGDiclofenac oral + Placebo Oral

Diclofenac oral + Placebo Oral

DRUGDiclofenac oral + scopolamina oral

Diclofenac oral + scopolamina oral

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

RCT, blind

Intervention model description

RCT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame	Description
Pain measure	until 1 hour after exam	Pain Visual analogue score

Secondary

Measure	Time frame	Description
Likert scale	until 1 hour after exam	Likert scale

Countries

Brazil

Contacts

Primary ContactCarlos A Souza, MD

cbsouza@hcpa.edu.br+5551981189937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026