Effect of Pre-medication in Pain Measures on Office Hysteroscopy

H

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

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

Trial contacts and locations

1

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Central trial contact

Carlos A Souza, MD

Data sourced from clinicaltrials.gov

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