Study of Pain Control in Diagnostic Hysteroscopy

Phramongkutklao College of Medicine and Hospital58 enrolled

Overview

The goal of this clinical trial study is to learn about how to decrease the pain during the diagnostic hysteroscopy. The main question it aims to answer is "Do the Paracetamol and Ibuprofen taken before the procedure can lower the pain during the diagnostic hysteroscopy".

After the participants those are indicated for diagnostic hysteroscopy and eligible for the study undergo informed consent, then they were divided to two groups for control group those get no medication and study group those get Paracetamol 500mg and Ibuprofen40mg per oral before the hysteroscopy, and both group needs to evaluate the pain score in VAS before, during hysteroscopy and after hysteroscopy for 30 minutes to compare the pain level in two groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Pain, Postoperative

Interventions

Ibuprofen-ParacetamolCOMBINATION_PRODUCT

Ibuprofen 40mg and Paracetamol 500mg per oral, single dose each, in study group 30minutes before hysteroscopic procedure

Eligibility

Sex: FEMALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old Exclusion Criteria: * Women with contraindication for undergoing diagnostic hysteroscopy includes women with pregnancy, uterine infection, diagnosed with cervical cancer or endometrium cancer and women who is undergoing with active vaginal bleeding * Women with history of allergy to Paracetamol or Ibuprofen medicine * Women with currently or pre-existing medical conditions that contraindicate the use of ibuprofen includes kidney disease, heart disease, cirrhosis, gastritis or individuals with a history of peptic ulcer or gastrointestinal bleeding * Women with currently taking anticoagulant or antiplatelet medications * Women with history of psychiatric disorders

Locations (1)

Phramongkutklao College of Medicine and Hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

The pain score comparing between study and control group

Comparing the pain score in visual analogue scale of 1(minimum) to 10scores(maximum) which is less to more painful respectively(higher score means more painful and worse outcome)

Time frame: During and 30minutes after the hysteroscopic procedure

Secondary Outcomes

The associated factors effecting the pain of the procedure

Comparing the pain score in visual analogue scale of 1(minimum) to 10scores (maximum) which is less to more painful respectively(higher score means more painful and worse outcome)between the participants with the possible associated factor effecting the pain of the procedure those are history of undergo vaginal delivery, history of undergo the hysteroscopy procedure and post menopause in both control group(no medication) and study group(Paracetamol and Ibuprofen)

Time frame: During and 30minutes after the hysteroscopic procedure

Data from ClinicalTrials.gov

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