Effect of Pre-medication in Pain Measures on Office Hysteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

RCT

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

RCT, blind

Study Groups

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Placebo Oral + Placebo Oral

Group Type PLACEBO_COMPARATOR

Placebo Oral + Placebo Oral

Intervention Type DRUG

Placebo Oral + Placebo Oral

Diclofenac oral + Placebo Oral

Group Type ACTIVE_COMPARATOR

Diclofenac oral + Placebo Oral

Intervention Type DRUG

Diclofenac oral + Placebo Oral

Diclofenac oral + scopolamina oral

Group Type ACTIVE_COMPARATOR

Diclofenac oral + scopolamina oral

Intervention Type DRUG

Diclofenac oral + scopolamina oral

Interventions

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Placebo Oral + Placebo Oral

Intervention Type DRUG

Diclofenac oral + Placebo Oral

Intervention Type DRUG

Diclofenac oral + scopolamina oral

Intervention Type DRUG

Other Intervention Names

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Placebo Diclofenac 50 mg oral tablet Diclofenac 50 mg oral tablet, scopolamin 10 mg oral tablet

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No