Efficacy of Oral Paracetamol Compared With Oral Ketoprofen for Pain Management in Office Hysteroscopy
NCT ID: NCT07315698
Last Updated: 2026-01-02
Study Results
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Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2020-11-01
2025-08-22
Brief Summary
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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.
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Detailed Description
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The study procedures include:
1. Conducting interviews to obtain sociodemographic information, current and past medical history, pregnancy history, medication use, and drug allergy history.
2. Performing a physical examination and additional diagnostic tests to determine the participant's health status.
3. Randomly allocating participants into two groups using simple randomization.
4. 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.
5. 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.
6. Evaluating side effects, patient comfort, and vagal reflexes using validated questionnaires.
7. Recording and analyzing all obtained data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Ketoprofen 100 mg orally for Office Hysteroscopy Pre-Medication
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.
Ketoprofen 100mg
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 orally for Office Hysteroscopy Pre-Medication
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.
Paracetamol 1000 Mg Oral Tablet
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.
Interventions
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Ketoprofen 100mg
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 Tablet
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not using analgesics one month before joining the study
Exclusion Criteria
* Women with a history of Allergy to Paracetamol or NSAID class drugs
FEMALE
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Dr. dr. Tricia Dewi Anggraeni, Sp.OG, Subsp. Onk
Associate Professor of Gynecologic Oncology Division
Locations
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RSCM Kintani
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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References
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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.
Hawkey 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.
Tenenbaum J. The epidemiology of nonsteroidal anti-inflammatory drugs. Can J Gastroenterol. 1999 Mar;13(2):119-22. doi: 10.1155/1999/361651.
el Valle, C.; Solano, J.A.; RodrÃguez, A.; Alonso, M. Pain management in outpatient hysteroscopy. Gynecol Minim Invasive Ther. 2016;5(4):141-7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-08-0983
Identifier Type: -
Identifier Source: org_study_id
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