Tesis

Perbandingan Efektivitas dan Efek Samping Sedasi Analgesia Prosedural Kombinasi Midazolam dan Ketamin Intranasal Menggunakan Mucosal Atomization Device dengan Intramuskular pada Pemasangan Cental Venous Catheter Pasien Anak Usia 6 Bulan–5 Tahun = A Comparative Study of the Effectiveness and Side Effects of Procedural Sedation and Analgesia Using an Intranasal Midazolam-Ketamine Combination via a Mucosal Atomization Device Versus Intramuscular Administration for Central Venous Catheter Placement in Pediatric Patients Aged 6 Months to 5 Years.

Latar Belakang: Pemasangan Cental Venous Catheter (CVC ) pada anak membutuhkan sedasi analgesia adekuat. Kombinasi ketamin dan midazolam sering digunakan karena efektif mengatasi nyeri, efek ansietas, dan depresi nafas lebih minimal. Saat jalur intravena tidak tersedia, kombinasi ini diberikan secara intramuskular. Pemberian intramuskular menimbulkan efek yang tidak langsung terlihat, nyeri, dan ketakutan. Sedasi analgesia prosedural intranasal menggunakan mucosal atomization device (MAD) merupakan alternatif yang efektif, aman, tidak nyeri, lebih nyaman, dan ditoleransi baik. Tujuan: Mengetahui perbedaan efektivitas dan efek samping sedasi analgesia prosedural kombinasi midazolam dan ketamin intranasal menggunakan MAD dengan intramuskular pada pemasangan CVC pasien anak usia 6 bulan–5 tahun. Metode: Open label randomized controlled trial, melibatkan anak berusia 6 bulan-5 tahun yang memerlukan pemasangan CVC. Total 30 subjek dibagi dua kelompok sedasi analgesia prosedural: kelompok intranasal MAD (midazolam 0,2mg/kg + ketamin 0,5mg/kg) dan intramuskular (midazolam 0,1mg/kg + ketamin 2mg/kg). Penilaian skala COMFORT-B dilakukan di menit ke-10, 20, dan 30 selama pemasangan CVC. Tanda vital dan munculnya efek samping dipantau. Skala kepuasan operator menurut Likert terhadap sedasi analgesia prosedural dinilai pada akhir penelitian. Hasil: Tidak terdapat perbedaan signifikan nilai median COMFORT-B pada kelompok intranasal MAD di menit ke-10: 12(RIK11-14), ke-20: 12(RIK11-12), dan ke-30: 11(RIK 11-12) dibandingkan intramuskular di menit ke-10: 13(RIK10-16), ke-20: 11(RIK8-14), dan ke-30: 11(RIK8-15), dengan nilai p > 0,05. Tidak terdapat perbedaan signifikan pada tanda vital dan efek samping diantara kedua kelompok. Terdapat perbedaan signifikan skala kepuasan operator menurut Likert yang lebih tinggi pada kelompok intranasal MAD dibandingkan intramuskular. Kesimpulan: Sedasi analgesia prosedural kombinasi midazolam dan ketamin intranasal menggunakan MAD memiliki efektivitas yang sama dengan intramuskular tanpa efek samping yang serius dan tingkat kepuasan operator yang lebih baik pada pemasangan CVC anak usia 6 bulan–5 Tahun.
Kata kunci: anak; central venous catheter; intranasal; ketamin; midazolam; sedasi analgesia prosedural.


Background: The insertion of a central venous catheter (CVC) in pediatric patients requires adequate procedural sedation and analgesia. The combination of ketamine and midazolam is commonly used due to its effectiveness in pain control, anxiolytic effects, and minimal respiratory depression. When intravenous access is not available, this combination is administered intramuscularly. However, intramuscular administration can be painful, induce fear, and result in delayed onset of action. Intranasal procedural sedation and analgesia using a mucosal atomization device (MAD) is an effective, safe, painless, more comfortable, and well-tolerated alternative. Objective: To compare the effectiveness and side effects of intranasal (via MAD) versus intramuscular administration of a midazolam-ketamine combination for procedural sedation and analgesia during CVC insertion in children aged 6 months to 5 years. Methods: This open-label randomized controlled trial involved children aged 6 months to 5 years requiring CVC insertion. A total of 30 subjects were randomized into two procedural sedation groups: the intranasal MAD group (midazolam 0.2 mg/kg + ketamine 0.5 mg/kg) and the intramuscular group (midazolam 0.1 mg/kg + ketamine 2 mg/kg). COMFORT-B scale assessments were conducted at 10, 20, and 30 minutes during the procedure. Vital signs and side effects were monitored throughout. Operator satisfaction was measured using a Likert scale at the end of the study. Results: There were no significant differences in the median COMFORT-B scales between the intranasal MAD group at minute 10: 12 (IQR 11–14), minute 20: 12 (IQR 11–12), and minute 30: 11 (IQR 11–12) and the intramuscular group at minute 10: 13 (IQR 10–16), minute 20: 11 (IQR 8–14), and minute 30: 11 (IQR 8–15), with p > 0.05. No significant differences were observed in vital signs or side effects between the two groups. Operator satisfaction scores were significantly higher in the intranasal MAD group compared to the intramuscular group. Conclusion: Intranasal procedural sedation and analgesia using a combination of midazolam and ketamine administered via MAD is as effective as intramuscular administration, with no serious side effects and higher operator satisfaction during CVC insertion in children aged 6 months to 5 years.
Keywords: central venous catheter; intranasal; ketamine; midazolam; pediatric, procedural sedation analgesia.