Efficacy of Oral Paracetamol Compared With Oral Ketoprofen for Pain Management in Office Hysteroscopy: A Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Intensity of Pain During Office-Hysteroscopy Procedure
研究概览
简要总结
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.
详细描述
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:
- Conducting interviews to obtain sociodemographic information, current and past medical history, pregnancy history, medication use, and drug allergy history.
- Performing a physical examination and additional diagnostic tests to determine the participant's health status.
- Randomly allocating participants into two groups using simple randomization.
- 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.
- 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.
- Evaluating side effects, patient comfort, and vagal reflexes using validated questionnaires.
- Recording and analyzing all obtained data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who underwent an office-hysteroscopy procedure
- •Not using analgesics one month before joining the study
排除标准
- •Women with a history of Asthma
- •Women with a history of Allergy to Paracetamol or NSAID class drugs
研究组 & 干预措施
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.
干预措施: Ketoprofen 100mg (Drug)
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.
干预措施: Paracetamol 1000 Mg Oral Tablet (Drug)
结局指标
主要结局
The Intensity of Pain During Office-Hysteroscopy Procedure
时间窗: During the 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
次要结局
- Cramping Pain Score within 30 Minutes After Office-Hysteroscopy Procedure(Within 30 minutes after office-hysteroscopy procedure)
研究者
Dr. dr. Tricia Dewi Anggraeni, Sp.OG, Subsp. Onk
Associate Professor of Gynecologic Oncology Division
Indonesia University