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

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.

Study Overview

• Status: Completed
• Conditions: Office Hysteroscopy
• Intervention / Treatment: Drug: Ketoprofen 100mg; Drug: Paracetamol 1000 Mg Oral Tablet

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Special Capital Region
    • Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
      • RSCM Kintani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Ketoprofen 100mg orally
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Cramping Pain Score within 30 Minutes After Office-Hysteroscopy Procedure	Within 30 minutes after office-hysteroscopy procedure

Collaborators and Investigators

• Sponsor: Indonesia University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): August 22, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Women's Health; Visual Analogue Scale; Non-steroidal Anti-inflammatory Drugs; Analgesic Efficacy; Office Hysteroscopy; Gynecologic Endoscopy; Outpatient Procedure
• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Dosage Forms; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acids, Carbocyclic; Phenylpropionates; Acetaminophen; Ketoprofen; Tablets
• Other Study ID Numbers: 20-08-0983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No