Clinical trial

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

Name
PMK-019
Description
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".
Trial arms
Trial start
2022-12-22
Estimated PCD
2023-06-22
Trial end
2023-06-22
Status
Completed
Treatment
Ibuprofen-Paracetamol
Ibuprofen 40mg and Paracetamol 500mg per oral, single dose each, in study group 30minutes before hysteroscopic procedure
Arms:
Ibuprofen-Paracetamol
Size
58
Primary endpoint
The pain score comparing between study and control group
During and 30minutes after the hysteroscopic procedure
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}
Updated at
2024-01-03

1 organization

1 product

2 indications

Indication
Pain
Indication
Postoperative