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

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Office Hysteroscopy

Treatments: Drug: Paracetamol 1000 Mg Oral Tablet; Drug: Ketoprofen 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07315698

20-08-0983

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ketoprofen 100 mg orally for Office Hysteroscopy Pre-Medication

Active Comparator group

Description:

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.

Treatment:

Drug: Ketoprofen 100mg

Paracetamol 1000 mg orally for Office Hysteroscopy Pre-Medication

Active Comparator group

Description:

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.

Treatment:

Drug: Paracetamol 1000 Mg Oral Tablet