Effect of Pre-medication in Pain Measures on Office Hysteroscopy

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 4

Conditions: Pain

Treatments: Drug: Placebo Oral + Placebo Oral; Drug: Diclofenac oral + Placebo Oral; Drug: Diclofenac oral + scopolamina oral

Study type: Interventional

Funder types: Other

Identifiers

NCT03506763

65409017.0.0000.5327

Details and patient eligibility

About

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.

Full 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

Enrollment: 231 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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231 participants in 3 patient groups, including a placebo group

Placebo Oral + Placebo Oral

Placebo Comparator group

Description:

Placebo Oral + Placebo Oral

Treatment:

Drug: Placebo Oral + Placebo Oral

Diclofenac oral + Placebo Oral

Active Comparator group

Description:

Diclofenac oral + Placebo Oral

Treatment:

Drug: Diclofenac oral + Placebo Oral

Diclofenac oral + scopolamina oral

Active Comparator group

Description:

Diclofenac oral + scopolamina oral

Treatment:

Drug: Diclofenac oral + scopolamina oral