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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketoprofen 100mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the office-hysteroscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cramping Pain Score within 30 Minutes After Office-Hysteroscopy Procedure | Within 30 minutes after office-hysteroscopy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSCM Kintani | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24835860 | Background | 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. | |
| 2106956 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2020 | Dec 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007660 | Ketoprofen |
| D000082 | Acetaminophen |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Paracetamol 1000 Mg Oral Tablet | Drug | 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. |
|
| 10203429 | Background | Tenenbaum J. The epidemiology of nonsteroidal anti-inflammatory drugs. Can J Gastroenterol. 1999 Mar;13(2):119-22. doi: 10.1155/1999/361651. |
| Background | el Valle, C.; Solano, J.A.; RodrÃguez, A.; Alonso, M. Pain management in outpatient hysteroscopy. Gynecol Minim Invasive Ther. 2016;5(4):141-7. |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |