Study of Pain Control in Diagnostic Hysteroscopy

NCT06188143 | Completed

• 1 other identifier: PMK-019
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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".

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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)

  During and 30minutes after the hysteroscopic procedure

Secondary Outcomes (1)

• The associated factors effecting the pain of the procedure

  During and 30minutes after the hysteroscopic procedure

Study Arms (2)

Control group

NO INTERVENTION

No medication before hysteroscopic procedure

Ibuprofen-Paracetamol

EXPERIMENTAL

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

Combination Product: Ibuprofen-Paracetamol

Interventions

Ibuprofen-Paracetamol COMBINATION_PRODUCT

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

Ibuprofen-Paracetamol

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (1)

Phramongkutklao College of Medicine and Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 3, 2024
• Study Start: December 22, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)