Tesis

Efikasi Penggunaan Parasetamol Per Oral Dibandingkan Dengan Ketoprofen Per Oral Untuk Manajemen Nyeri Dalam Office Hysteroscopy = Efficacy of Oral Paracetamol Compared with Oral Ketoprofen for Pain Management in Office Hysteroscopy.

Latar Belakang: Nyeri masih menjadi penyebab utama kegagalan prosedur office hysteroscopy. Obat anti inflamasi nonsteroid (OAINS), salah satunya ketoprofen masih digunakan secara rutin untuk mengatasi nyeri selama prosedur office hysteroscopy. Namun penggunaan ketoprofen menimbulkan beberapa efek samping, paling sering pada saluran pencernaan dengan gejala dan tanda seperti mual, muntah, dispepsia, diare, dan ulkus peptikum. Dalam pedoman RCOG (Royal College of Obstetricians and Gynaecologists), parasetamol juga dapat digunakan dalam manajemen nyeri untuk office hysteroscopy. Namun, belum ada bukti klinis yang menunjukkan efikasi parasetamol untuk manajemen nyeri pada office hysteroscopy. Tujuan: Untuk mengetahui efikasi pemberian parasetamol tablet 1000 mg per oral dibandingkan dengan ketoprofen tablet 100 mg per oral dalam manajemen nyeri saat prosedur office hysteroscopy dan cramping 30 menit setelah prosedur office hysteroscopy serta efek samping, refleks vagal, dan tingkat kenyamanan pada pasien selama prosedur. Metode: Penelitian ini merupakan uji klinis acak tersamar ganda untuk menilai intensitas nyeri selama prosedur office hysteroscopy dan cramping dalam 30 menit setelah prosedur office hysteroscopy pada kelompok parasetamol 1000 mg per oral dibandingkan dengan kelompok ketoprofen 100 mg per oral. Kedua kelompok masing-masing terdiri dari 30 subjek. Alokasi subjek dilakukan dengan randomisasi blok. Penilaian intensitas nyeri selama prosedur (saat alat hysteroscope masuk ke dalam ostium uteri externum) dan cramping dalam 30 menit setelah prosedur office hysteroscopy dilakukan dengan menggunakan Visual Analogue Scale (VAS) dalam kuesioner. Hasil: Karakteristik subjek penelitian mempunyai usia rata-rata 48,3 tahun dengan durasi prosedur rata-rata 26 menit. Sebagian besar subjek adalah multipara (55%), belum menopause (53,3%), tidak ada dismenore (80%), tidak ada nyeri panggul kronik (90%), dan tidak pernah sectio caesaria (75%). Baik pada kelompok parasetamol maupun kelompok ketoprofen tidak bermakna secara statistik terhadap nyeri selama prosedur (nilai p = 0,266), dan cramping setelah 30 menit prosedur (nilai p = 0,499). Sebagian besar subjek merasakan nyeri dengan median 2 (0 – 8), cramping 30 menit setelah tindakan dengan median 0 (0 – 5), dan tingkat kenyamanan dengan median 9 (7 – 10). Selain itu, sebagian besar subjek tidak merasakan efek samping apapun (95%) dan seluruhnya tidak mengalami refleks vagal (100%). Kesimpulan: Tidak ada perbedaan bermakna nilai VAS pada pemberian parasetamol 1000 mg tablet per oral dibandingkan dengan ketoprofen 100 mg tablet per oral untuk manajemen nyeri selama prosedur dan cramping 30 menit pasca prosedur office hysteroscopy.
Kata kunci: office hysteroscopy, ketoprofen, parasetamol, pain, efek samping


Introduction: Pain is still the main cause of failure of office hysteroscopy procedures. Nonsteroidal anti-inflammatory drugs (NSAIDs), one of which is ketoprofen, are still used routinely to treat pain during office hysteroscopy procedures. However, the use of ketoprofen causes several side effects, most often in the digestive tract with symptoms and signs such as nausea, vomiting, dyspepsia, diarrhea and peptic ulcers. In the RCOG (Royal College of Obstetricians and Gynecologists) guidelines, paracetamol can also be used in pain management for office hysteroscopy. However, there is no clinical evidence showing the efficacy of paracetamol for pain management during office hysteroscopy. Objective: To determine the efficacy of administering paracetamol tablets 1000 mg orally compared with ketoprofen tablets 100 mg orally in managing pain during office hysteroscopy procedures and cramping 30 minutes after office hysteroscopy procedures as well as side effects, vagal reflexes, and the level of comfort in patients during the procedure. Methods: This study was a double-blind, randomized clinical trial to assess the intensity of pain during the office hysteroscopy procedure and cramping within 30 minutes after the office hysteroscopy procedure in the paracetamol 1000 mg orally group compared with the ketoprofen 100 mg orally group. Both groups each consisted of 30 subjects. Subject allocation was carried out by block randomization. Assessment of pain intensity during the procedure (when the hysteroscope instrument enters the external uterine ostium) and cramping within 30 minutes after the office hysteroscopy procedure was carried out using the Visual Analogue Scale (VAS) in the questionnaire. Results: The characteristics of the research subjects were an average age of 48.3 years with an average procedure duration of 26 minutes. Most of the subjects were multiparous (55%), had not had menopause (53.3%), had no dysmenorrhea (80%), had no chronic pelvic pain (90%), and had never had a caesarean section (75%). Neither the paracetamol group nor the ketoprofen group had statistical significance regarding pain during the procedure (p value = 0.266), and cramping after 30 minutes of the procedure (p value = 0.499). Most subjects felt pain with a median of 2 (0 – 8), cramping 30 minutes after the procedure with a median of 0 (0 – 5), and a comfort level with a median of 9 (7 – 10). In addition, the majority of subjects did not feel any side effects (95%) and all did not experience vagal reflexes (100%). Conclusion: There was no significant difference in VAS scores when administering paracetamol 1000 mg tablets orally compared with ketoprofen 100 mg tablets orally for pain management during the procedure and cramping 30 minutes after the office hysteroscopy procedure.
Keywords: office hysteroscopy, ketoprofen, paracetamol, pain, side effects