Effect of Pre-medication in Pain Measures on Office Hysteroscopy

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo Oral + Placebo Oral; Drug: Diclofenac oral + Placebo Oral; Drug: Diclofenac oral + scopolamina oral

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

• Study Type: Interventional
• Enrollment (Anticipated): 231
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Carlos A Souza, MD; Phone Number: +5551981189937; Email: souza.cab@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Oral + Placebo Oral	Drug: Placebo Oral + Placebo Oral; Placebo Oral + Placebo Oral; Other Names: Placebo
Active Comparator: Diclofenac oral + Placebo Oral	Drug: Diclofenac oral + Placebo Oral; Diclofenac oral + Placebo Oral; Other Names: Diclofenac 50 mg oral tablet
Active Comparator: Diclofenac oral + scopolamina oral	Drug: Diclofenac oral + scopolamina oral; Diclofenac oral + scopolamina oral; Other Names: Diclofenac 50 mg oral tablet, scopolamin 10 mg oral tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert scale	Likert scale	until 1 hour after exam

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Joao Sabino, MD, HCPA- Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: office hysteroscopy, pain measure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 65409017.0.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No