Office HysteroscopyPhase 4NCT07315698
Efficacy of Oral Paracetamol Compared With Oral Ketoprofen for Pain Management in Office Hysteroscopy
A Phase 4 study testing Ketoprofen 100mg and Paracetamol 1000 Mg Oral Tablet in people with Office Hysteroscopy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Hysteroscopy is a procedure used to evaluate abnormalities within the uterus (intrauterine. Currently, hysteroscopy can be performed in an outpatient clinic setting according to established standards, known as office hysteroscopy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Office Hysteroscopy
- What is being tested?
- Ketoprofen 100mg and Paracetamol 1000 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2020to 22 Aug 2025
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who underwent an office-hysteroscopy procedure
- Not using analgesics one month before joining the study
Who cannot join
- Women with a history of Asthma
- Women with a history of Allergy to Paracetamol or NSAID class drugs
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSCM Kintani
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Efficacy of Oral Paracetamol Compared With Oral Ketoprofen for Pain Management in Office Hysteroscopy: A Double-Blind Randomized Clinical Trial
Hysteroscopy is a procedure used to evaluate abnormalities within the uterus (intrauterine. Currently, hysteroscopy can be performed in an outpatient clinic setting according to established standards, known as office hysteroscopy. Although office hysteroscopy offers greater comfort compared with hysteroscopy performed in the operating room, the procedure can still cause pain for patients.
At Dr. Cipto Mangunkusumo National General Hospital, one of the analgesics routinely used for office hysteroscopy is ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) administered rectally. However, ketoprofen frequently causes uncomfortable side effects such as nausea, vomiting, and diarrhea, making alternative analgesics necessary-particularly for patients with contraindications to NSAIDs, including those with allergic reactions. In addition, rectal administration is less practical and less comfortable for patients compared with oral administration.
Therefore, an alternative analgesic with fewer side effects and a more practical route of administration is needed for pain management during office hysteroscopy. Further evaluation is required to assess the efficacy of paracetamol compared with ketoprofen as an alternative analgesic for pain management in office hysteroscopy. Adequate pain management is expected to enhance the overall success of the procedure.
Read the detailed description
This study will be conducted over a six-months period and involves interview-based data collection and pain assessments integrated with the office hysteroscopy procedure visit. Each participant undergoes an interview of approximately 20 minutes at the beginning of the visit, followed by pain assessments at the time of hysteroscope insertion and again 30 minutes after the procedure is completed.
The study procedures include:
- Conducting interviews to obtain sociodemographic information, current and past medical history, pregnancy history, medication use, and drug allergy history.
- Performing a physical examination and additional diagnostic tests to determine the participant's health status.
- Randomly allocating participants into two groups using simple randomization.
- Administering analgesic interventions according to group allocation: the first group receives 1000 mg of oral paracetamol, and the second group receives 100 mg of oral ketoprofen, both given one hour before office hysteroscopy. The medications are provided in tablet form and taken with water after a meal.
- Assessing pain intensity using the Visual Analogue Scale (VAS) at hysteroscope insertion into the external cervical ostium and again 30 minutes after the procedure is completed.
- Evaluating side effects, patient comfort, and vagal reflexes using validated questionnaires.
- Recording and analyzing all obtained data.
- Conditions
- Office Hysteroscopy
- Being tested
- Ketoprofen 100mg, Paracetamol 1000 Mg Oral Tablet
- Keywords
- Office Hysteroscopy, Gynecologic Endoscopy, Outpatient Procedure, Visual Analogue Scale, Non-steroidal Anti-inflammatory Drugs, Women's Health, Analgesic Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen 100mgDrug
Also called Ketoprofen 100mg orally
Ketoprofen 100 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure.
Paracetamol 1000 Mg Oral TabletDrug
Paracetamol 1000 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen 100 mg orally for Office Hysteroscopy Pre-Medication | Active comparator | Ketoprofen 100 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure. Receives: Drug: Ketoprofen 100mg |
| Paracetamol 1000 mg orally for Office Hysteroscopy Pre-Medication | Active comparator | Paracetamol 1000 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure. Receives: Drug: Paracetamol 1000 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Intensity of Pain During Office-Hysteroscopy Procedure
The intensity of pain during office-hysteroscopy procedure, measured using a visual analogue scale when the hysteroscope entered the external cervical ostium
Measured: During the office-hysteroscopy procedure
Secondary outcomes (1)
Cramping Pain Score within 30 Minutes After Office-Hysteroscopy Procedure
Measured: Within 30 minutes after office-hysteroscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Nov 2020
- Primary completion30 May 2023
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Office HysteroscopyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Tricia Dewi Anggraeni, Sp.OG, Subsp. Onk, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315698
- Sponsor's protocol ID
- 20-08-0983
- Status last verified
- Oct 2020
- First submitted
- 14 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teran-Alonso MJ, De Santiago J, Usandizaga R, Zapardiel I. Evaluation of pain in office hysteroscopy with prior analgesic medication: a prospective randomized study. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:123-7. doi: 10.1016/j.ejogrb.2014.04.030. Epub 2014 May 6.
PubMed 24835860Hawkey CJ. Non-steroidal anti-inflammatory drugs and peptic ulcers. BMJ. 1990 Feb 3;300(6720):278-84. doi: 10.1136/bmj.300.6720.278. No abstract available.
PubMed 2106956Tenenbaum J. The epidemiology of nonsteroidal anti-inflammatory drugs. Can J Gastroenterol. 1999 Mar;13(2):119-22. doi: 10.1155/1999/361651.
PubMed 10203429el Valle, C.; Solano, J.A.; Rodríguez, A.; Alonso, M. Pain management in outpatient hysteroscopy. Gynecol Minim Invasive Ther. 2016;5(4):141-7.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Paracetamol Compared With Oral Ketoprofen for Pain Management in Office Hysteroscopy: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07315698
- Acronym / sponsor ID
- 20-08-0983
- Conditions
- Office Hysteroscopy
- Keywords
- Office Hysteroscopy, Gynecologic Endoscopy, Outpatient Procedure, Visual Analogue Scale, Non-steroidal Anti-inflammatory Drugs, Women's Health, Analgesic Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 2 Jan 2026 (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.
Hysteroscopy is a procedure used to evaluate abnormalities within the uterus (intrauterine. Currently, hysteroscopy can be performed in an outpatient clinic setting according to established standards, known as office hysteroscopy. Although office hysteroscopy offers greater comfort compared with hysteroscopy performed in the operating room, the procedure can still cause pain for patients.
At Dr. Cipto Mangunkusumo National General Hospital, one of the analgesics routinely used for office hysteroscopy is ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) administered rectally. However, ketoprofen frequently causes uncomfortable side effects such as nausea, vomiting, and diarrhea, making alternative analgesics necessary-particularly for patients with contraindications to NSAIDs, including those with allergic reactions. In addition, rectal administration is less practical and less comfortable for patients compared with oral administration.
Therefore, an alternative analgesic with fewer side effects and a more practical route of administration is needed for pain management during office hysteroscopy. Further evaluation is required to assess the efficacy of paracetamol compared with ketoprofen as an alternative analgesic for pain management in office hysteroscopy. Adequate pain management is expected to enhance the overall success of the procedure.
Detailed description
This study will be conducted over a six-months period and involves interview-based data collection and pain assessments integrated with the office hysteroscopy procedure visit. Each participant undergoes an interview of approximately 20 minutes at the beginning of the visit, followed by pain assessments at the time of hysteroscope insertion and again 30 minutes after the procedure is completed.
The study procedures include:
- Conducting interviews to obtain sociodemographic information, current and past medical history, pregnancy history, medication use, and drug allergy history.
- Performing a physical examination and additional diagnostic tests to determine the participant's health status.
- Randomly allocating participants into two groups using simple randomization.
- Administering analgesic interventions according to group allocation: the first group receives 1000 mg of oral paracetamol, and the second group receives 100 mg of oral ketoprofen, both given one hour before office hysteroscopy. The medications are provided in tablet form and taken with water after a meal.
- Assessing pain intensity using the Visual Analogue Scale (VAS) at hysteroscope insertion into the external cervical ostium and again 30 minutes after the procedure is completed.
- Evaluating side effects, patient comfort, and vagal reflexes using validated questionnaires.
- Recording and analyzing all obtained data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprofen 100 mg orally for Office Hysteroscopy Pre-Medication | Active comparator | Drug: Ketoprofen 100mgKetoprofen 100 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure. |
| Paracetamol 1000 mg orally for Office Hysteroscopy Pre-Medication | Active comparator | Drug: Paracetamol 1000 Mg Oral TabletParacetamol 1000 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women who underwent an office-hysteroscopy procedure
- Not using analgesics one month before joining the study
Key exclusion criteria (2 listed)
- Women with a history of Asthma
- Women with a history of Allergy to Paracetamol or NSAID class drugs
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 |
|---|---|---|
| Ketoprofen 100mgAlso: Ketoprofen 100mg orallyKetoprofen 100 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure. | Drug | Ketoprofen 100 mg orally for Office Hysteroscopy Pre-Medication |
| Paracetamol 1000 Mg Oral TabletParacetamol 1000 mg orally for office hysteroscopy procedure pre-medication 60 minutes before the procedure. Then, assessing the intensity of pain during the procedure and cramping within 30 minutes after the procedure. | Drug | Paracetamol 1000 mg orally for Office Hysteroscopy Pre-Medication |
Primary outcome
The Intensity of Pain During Office-Hysteroscopy Procedure
Time frame: During the office-hysteroscopy procedure
The intensity of pain during office-hysteroscopy procedure, measured using a visual analogue scale when the hysteroscope entered the external cervical ostium
1 secondary outcome
Cramping Pain Score within 30 Minutes After Office-Hysteroscopy Procedure
Time frame: Within 30 minutes after office-hysteroscopy 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 2 Jan 2026.
- Background: PubMed 24835860Teran-Alonso MJ, De Santiago J, Usandizaga R, Zapardiel I. Evaluation of pain in office hysteroscopy with prior analgesic medication: a prospective randomized study. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:123-7. doi: 10.1016/j.ejogrb.2014.04.030. Epub 2014 May 6.
- Background: PubMed 2106956Hawkey CJ. Non-steroidal anti-inflammatory drugs and peptic ulcers. BMJ. 1990 Feb 3;300(6720):278-84. doi: 10.1136/bmj.300.6720.278. No abstract available.
- Background: PubMed 10203429Tenenbaum J. The epidemiology of nonsteroidal anti-inflammatory drugs. Can J Gastroenterol. 1999 Mar;13(2):119-22. doi: 10.1155/1999/361651.
- Backgroundel Valle, C.; Solano, J.A.; Rodríguez, A.; Alonso, M. Pain management in outpatient hysteroscopy. Gynecol Minim Invasive Ther. 2016;5(4):141-7.
- Individual participant dataSharing planned: No
Related trials for Office Hysteroscopy
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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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 Phase 4 study testing Ketoprofen 100mg and Paracetamol 1000 Mg Oral Tablet in people with Office Hysteroscopy, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 2 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 2 Jan 2026. 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 Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Intensity of Pain During Office-Hysteroscopy Procedure (time frame: During the office-hysteroscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07315698, which also lists 4 linked publications.
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 2 Jan 2026.