Comparison of Naproxen and Paracetamol for pain relief during endometrial biopsy in non-pregnant women with abnormal uterine bleeding; A randomized controlled trial

Phase 4

• Conditions: Pain from endometrial biopsy by using manual vacuum aspiration; endometrial biopsy; manual vacuum aspiration; abnormal uterine bleeding; pain

• Registration Number: TCTR20230222001
• Lead Sponsor: Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-22
• Study Completion: 2024-02-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 198

Inclusion Criteria

1.)A non-pregnant woman who has abnormal bleeding from uterus, age between 30 - 70 years old, with one of following criteria
a.Age >/= 45 years
b.Age < 45 years with unopposed estrogen exposure or chronic anovulation
c.Persistent abnormal uterine bleeding
3.)Not an anti-platelet or anti-coagulant agents user
4.)Adequate communication with Thai
5.)Consented to join the trial

Exclusion Criteria

1. A woman who has had Paracetamol or NSAIDs agents within 24 hours before
2. A woman who has a history of allergy to NSAIDs or Paracetamol
3. A woman who has any contraindications in Naproxen using, such as peptic ulcer, asthma, bleeding disorder, and impaired renal or hepatic function; GFR < 30mL/min/1.73m2
4. A woman who has any contraindications in Paracetamol using, such as impaired liver function; AST >100 U/L or ALT > 100U/L), and alcoholism.
5. A woman who cannot understand the Visual Analogue Scale (VAS)
6. Participants who need to withdraw from the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain level immediately after the procedure finished and 10 minutes after the procedure Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A