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Perbandingan respons klinis dan efek samping semprot hidung salin (Air Laut) dengan tetes hidung salin pada anak balita dengan common cold = Clinical response and side effect of saline nasal spray (sea water) compared to saline nasal drops in children under 5 years old with common cold

Latar belakang. Keunggulan semprot hidung salin isotonik air laut pada anak balita dengan common cold masih kontroversi, dan studi pada anak balita masih sedikit. Dalam praktek sehari-hari, semprot hidung salin isotonik air laut telah banyak diberikan pada penderita common cold, walaupun efektifitas dan keamanannya pada anak balita belum pernah diteliti di Indonesia. Tujuan. Membandingkan respons klinis dan efek samping semprot hidung salin (air laut) dan tetes hidung salin pada pasien dengan common cold, melalui a) penurunan skor gejala hidung, b) penurunan skor suhu tubuh, c) lama sakit, dan d) efek samping (epistaksis). Metode. Suatu opened-label randomized clinical trial, dilaksanakan di Puskesmas Kecamatan Kalideres dengan subjek anak berusia 12-60 bulan. Subjek diberikan semprot hidung salin air laut dan sirup parasetamol (kelompok eksperimen) atau tetes hidung salin dan parasetamol (kelompok eksperimen) atau hanya parasetamol (kontrol) berdasarkan alokasi random. Semprot hidung salin (air laut) diberikan 3 kali sehari 1 semprot tiap lubang hidung selama 7 hari, tetes hidung salin diberikan 3 kali sehari 2 tetes tiap lubang hidung, selama 7 hari, dan parasetamol sirup diberikan 10 mg/kgbb tiap 4 jam bila suhu tubuh ≥ 38ºC. Penilaian skor gejala hidung, skor suhu tubuh, dilakukan sebelum dimulai pengobatan sampai dengan hari ke delapan. Sedangkan lama sakit dan efek samping obat dinilai dari awal pengobatan sampai sembuh Hasil. Sebanyak 68 subjek yang memenuhi kriteria inklusi dirandomisasi menjadi kelompok eksperimen (semprot hidung salin air laut dan tetes hidung salin) atau kontrol. Pada hari kedelapan pengobatan tidak terdapat perbedaan bermakna pada penurunan skor gejala hidung (p=0,976), skor suhu tubuh (p=0,884), dan lama sakit (p=0,805) antara ketiga kelompok penelitian. Tidak didapatkan efek samping berupa epistaksis Simpulan. Pada anak balita dengan common cold yang diberikan semprot hidung salin (air laut) dibandingkan dengan tetes hidung salin dan kontrol tidak terdapat perbedaan bermakna pada respons klinis dan efek samping.
Kata kunci: common cold, semprot hidung salin (air laut), tetes hidung salin, parasetamol, anak balita, epistaksis.


Background. Superiority of isotonic saline nasal spray (sea water) in children under 5 years old with common cold is still controversy, and studies in children under 5 year old are rare. In daily practice, isotonic (sea water) saline nasal spray have been given to patients with common cold, although its efficacy and safety in children under 5 year old haven’t been studied in Indonesia. Aim. To compare clinical response and side effect of of Saline Nasal Spray (Sea Water) with Saline Nasal Drops in Children under 5 year old with Common Cold, by assessing a) decrease nasal symptom scores, b) decrease body temperature score, c) day of well- being, and d) side effect (nose bleeding). Methods. This study is an opened-label randomized clinical trial, held in Puskesmas Kecamatan Kalideres on children 12-60 months old with common cold. Subject was given saline nasal spray and paracetamol (experiment group) or salin nasal drops and paracetamol (experiment group) or paracetamol alone according to random allocation. Saline nasal spray was given three times a day, one spray each nostril for seven days, saline nasal drops was given three times a day, two drops each nostril for seven days, and paracetamol was given 10 mg/kgbw every 4 hours when body temperature ≥ 38ºC. Observations included nasal symptom scores, body temperature score, were done from the first day until day eight of medication. Day of well-being and side effect were observed from the first day of medication until recover. Result. Sixty-eight patients were randomized to experiment or control group. At seven days post medication, there were no significant difference in nasal symptom scores (p=0.976), body temperature score (p=0.884), and day of well-being (p=0.805) among the study groups. Nose bleeding was not found. Conclusion. There were no significant difference in clinical response and side effect in children under five years old with common cold given isotonic saline nasal spray (sea water) compared with saline nasal drop.
Keywords. Common cold, saline nasal spray (sea water), saline nasal drop, paracetamol, children under five years old, nose bleed.