Study of Pain Control in Diagnostic Hysteroscopy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06188143
• Other study ID #: PMK-019
• Status: Completed
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: December 2023
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Thailand	Phramongkutklao College of Medicine and Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	During and 30minutes after the hysteroscopic procedure