Efficacy of Oral Paracetamol Compared With Oral Ketoprofen for Pain Management in Office Hysteroscopy

NCT07315698 | Completed Phase 4

• 1 other identifier: 20-08-0983
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Office Hysteroscopy

Keywords

Office Hysteroscopy; Gynecologic Endoscopy; Outpatient Procedure; Visual Analogue Scale; Non-steroidal Anti-inflammatory Drugs; Women's Health; Analgesic Efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cramping Pain Score within 30 Minutes After Office-Hysteroscopy Procedure

  Within 30 minutes after office-hysteroscopy procedure

Study Arms (2)

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.

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.

Drug: Paracetamol 1000 Mg Oral Tablet

Interventions

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.

Also known as: Ketoprofen 100mg orally

Ketoprofen 100 mg orally for Office Hysteroscopy Pre-Medication

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.

Paracetamol 1000 mg orally for Office Hysteroscopy Pre-Medication

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who underwent an office-hysteroscopy procedure
• Not using analgesics one month before joining the study

You may not qualify if:

• Women with a history of Asthma
• Women with a history of Allergy to Paracetamol or NSAID class drugs

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSCM Kintani

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (4)

• 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.

  PMID: 24835860 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.

  PMID: 2106956 BACKGROUND

• Tenenbaum J. The epidemiology of nonsteroidal anti-inflammatory drugs. Can J Gastroenterol. 1999 Mar;13(2):119-22. doi: 10.1155/1999/361651.

  PMID: 10203429 BACKGROUND

• el Valle, C.; Solano, J.A.; Rodríguez, A.; Alonso, M. Pain management in outpatient hysteroscopy. Gynecol Minim Invasive Ther. 2016;5(4):141-7.

  BACKGROUND

MeSH Terms

Interventions

Ketoprofen; Acetaminophen; Tablets

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gynecologic Oncology Division

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 2, 2026
• Study Start: November 1, 2020
• Primary Completion: May 30, 2023
• Study Completion: August 22, 2025
• Last Updated: January 2, 2026

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)