Pain, Postoperative
Conditions
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.
Interventions
COMBINATION_PRODUCTIbuprofen-Paracetamol
Ibuprofen 40mg and Paracetamol 500mg per oral, single dose each, in study group 30minutes before hysteroscopic procedure
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Thailand
Outcome results
None listed