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

NCT07315698 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-02

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-05-30
Completion
2025-08-22

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315698 on ClinicalTrials.gov