Pain, PostoperativeNCT06188143
Study of Pain Control in Diagnostic Hysteroscopy
A study testing Ibuprofen-Paracetamol in people with Pain, Postoperative, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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". Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ibuprofen-Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteThailand
- Study dates
- 22 Dec 2022to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Phramongkutklao College of Medicine and Hospital
Bangkok, 10400
About this study
Official title: The Efficacy of Combination of Ibuprofen and Paracetamol for 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".
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Ibuprofen-Paracetamol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen-ParacetamolCombination product
Ibuprofen 40mg and Paracetamol 500mg per oral, single dose each, in study group 30minutes before hysteroscopic procedure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Ibuprofen-Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During and 30minutes after the hysteroscopic procedure
Secondary outcomes (1)
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)
Measured: During and 30minutes after the hysteroscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start22 Dec 2022
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188143
- Sponsor's protocol ID
- PMK-019
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Combination of Ibuprofen and Paracetamol for Pain Control in Diagnostic Hysteroscopy
- ClinicalTrials.gov ID
- NCT06188143
- Acronym / sponsor ID
- PMK-019
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No medication before hysteroscopic procedure |
| Ibuprofen-Paracetamol | Experimental | Combination Product: Ibuprofen-ParacetamolIbuprofen 40mg and Paracetamol 500mg per oral, single dose each, before hysteroscopic procedure 30minutes |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with indication and informed to undergo diagnostic hysteroscopy over or equal the age of 20 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen-ParacetamolIbuprofen 40mg and Paracetamol 500mg per oral, single dose each, in study group 30minutes before hysteroscopic procedure | Combination product | Ibuprofen-Paracetamol |
Primary outcome
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)
1 secondary outcome
The associated factors effecting the pain of the procedure
Time frame: During and 30minutes after the hysteroscopic procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen-Paracetamol in people with Pain, Postoperative, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain score comparing between study and control group (time frame: During and 30minutes after the hysteroscopic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.