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Completed

NCT Number: NCT06188143

Study of Pain Control in Diagnostic Hysteroscopy

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".

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Phramongkutklao College of Medicine and Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen-Paracetamol

Combination Product

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

Primary outcomes

  1. The pain score comparing between study and control group

    Time frame: 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 outcomes

  1. The associated factors effecting the pain of the procedure

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Registry information

Official study title

The Efficacy of Combination of Ibuprofen and Paracetamol for Pain Control in Diagnostic Hysteroscopy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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