Study of Pain Control in Diagnostic Hysteroscopy

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Combination Product: Ibuprofen-Paracetamol

• Registration Number: NCT06188143
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

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".

Detailed Description

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 Timeline

• Study Start: 2022-12-22
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22
• Status Verified: 2023-12
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen-Paracetamol	Ibuprofen-Paracetamol	Ibuprofen 40mg and Paracetamol 500mg per oral, single dose each, before hysteroscopic procedure 30minutes

Primary Outcome Measures

Name	Time	Method
The pain score comparing between study and control group	During and 30minutes after the hysteroscopic 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)

Secondary Outcome Measures

Name	Time	Method
The associated factors effecting the pain of the procedure	During and 30minutes after the hysteroscopic 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)

Trial Locations

Locations (1)

Phramongkutklao College of Medicine and Hospital; 🇹🇭 Bangkok, Thailand