ABSTRAK
Latar belakang: Demam, pengurangan waktu tidur, nyeri dan reaksi lokal adalahbeberapa kejadian ikutan pasca imunisasi. Untuk mencegah hal tersebut baiktenaga medis maupun orang tua memberikan profilaksis parasetamol pascaimunisasi. Peraturam Menteri Kesehatan Republik Indonesia dan PedomanImunisasi IDAI belum menetapkan secara tegas boleh atau tidaknya pemberianprofilaksis parasetamol pasca imunisasi.Tujuan: Mengetahui efektivitas pemberian profilaksis parasetamol oral untukmencegah kejadian ikutan pasca imunisasi kombinasi DTwP-Hep B-Hib.Metode: Uji Klinis tersamar acak ganda (double blind randomized control trialI)dengan pemberian parasetamol dan plasebo pada pasien pasca imunisasikombinasi DTwP-Hep B-Hib di Puskesmas Kecamatan Kramat Jati danPuskesmas Kelurahan Batu Ampar selama September 2015 sampai Oktober 2015.Satu hari pasca imunisasi, kelompok perlakuan diberikan parasetamol (40-50mg/kgBB/hari), terbagi 4 dosis sedangkan kelompok kontrol, mendapatkanplasebo. Selama empat hari pasca imunisasi dilakukan pengukuran suhu aksila,lama tidur, dan reaksi inflamasi lokal.Hasil: Subjek penelitian ini terdiri dari 100 bayi yang mendapatkan imunisasikombinasi DTwP-Hep B-Hib ketiga. Karakteristik dasar meliputi usia, jeniskelamin, dan status gizi tidak berbeda di kedua kelompok. Subjek penelitianmendapatkan profilaksis parasetamol (50 subjek) dan profilaksis plasebo (50subjek). Seluruh subjek penelitian tidak demam, tidak mengalami gangguan tidur,dan tidak ditemukan reaksi lokal. Pemberian parasetamol 24 jam pasca imunisasiDTwP-Hep B-Hib menunjukkan penurunan suhu 0,1 OC - 0,2 OC yang bermaknasecara statistik (p < 0,05) pada 24 jam pertama pasca imunisasi. Pemberianparasetamol menunjukkan waktu tidur yang lebih lama namun tidak bermaknasecara statistik (p>0,05) pada lama tidur.ABSTRACT
Background: Fever, decreased sleep time, pain and local reaction are adverseevent following vaccination especially DTwP vaccine. Parent and also medicalstaff almost give paracetamol prophylactic to reduce adverse event aftervaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry ofHealth Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed ornot prophylactic administration of paracetamol post immunization.Objective: To asses the efficacy of prophylactic administration of paracetamolcompared with placebo for prevent adverse event after immunization.Meth0d: A randomized double-blind clinical trials by adminisert paracetamol andplacebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati districtprimary health care and Batu Ampar sub-distric primary health care duringSeptember 2015 to October 2015. One day after vaccination , the treatment groupwas given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while thecontrol group was given placebo . Axillary temperature , time of sleep , and localreactions was evaluated until 4 day after vaccination.Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50with placebo) after DTwP-Hep B-Hib third primary immunization. The baselinecharacteristic including age, gender, and nutritional status were similar in bothgroups . All subject showed no fever, no local reaction, and no sleep disturbance.Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showeda decrease in temperature of 0.1 OC - 0.2 OC (p<0.05) in the first 24 hours postimmunization.Administration of paracetamol showed longer sleep time (p> 0.05)in the first 24 hours post- immunization.;Background: Fever, decreased sleep time, pain and local reaction are adverseevent following vaccination especially DTwP vaccine. Parent and also medicalstaff almost give paracetamol prophylactic to reduce adverse event aftervaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry ofHealth Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed ornot prophylactic administration of paracetamol post immunization.Objective: To asses the efficacy of prophylactic administration of paracetamolcompared with placebo for prevent adverse event after immunization.Meth0d: A randomized double-blind clinical trials by adminisert paracetamol andplacebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati districtprimary health care and Batu Ampar sub-distric primary health care duringSeptember 2015 to October 2015. One day after vaccination , the treatment groupwas given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while thecontrol group was given placebo . Axillary temperature , time of sleep , and localreactions was evaluated until 4 day after vaccination.Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50with placebo) after DTwP-Hep B-Hib third primary immunization. The baselinecharacteristic including age, gender, and nutritional status were similar in bothgroups . All subject showed no fever, no local reaction, and no sleep disturbance.Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showeda decrease in temperature of 0.1 OC - 0.2 OC (p<0.05) in the first 24 hours postimmunization.Administration of paracetamol showed longer sleep time (p> 0.05)in the first 24 hours post- immunization.;Background: Fever, decreased sleep time, pain and local reaction are adverseevent following vaccination especially DTwP vaccine. Parent and also medicalstaff almost give paracetamol prophylactic to reduce adverse event aftervaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry ofHealth Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed ornot prophylactic administration of paracetamol post immunization.Objective: To asses the efficacy of prophylactic administration of paracetamolcompared with placebo for prevent adverse event after immunization.Meth0d: A randomized double-blind clinical trials by adminisert paracetamol andplacebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati districtprimary health care and Batu Ampar sub-distric primary health care duringSeptember 2015 to October 2015. One day after vaccination , the treatment groupwas given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while thecontrol group was given placebo . Axillary temperature , time of sleep , and localreactions was evaluated until 4 day after vaccination.Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50with placebo) after DTwP-Hep B-Hib third primary immunization. The baselinecharacteristic including age, gender, and nutritional status were similar in bothgroups . All subject showed no fever, no local reaction, and no sleep disturbance.Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showeda decrease in temperature of 0.1 OC - 0.2 OC (p<0.05) in the first 24 hours postimmunization.Administration of paracetamol showed longer sleep time (p> 0.05)in the first 24 hours post- immunization.;Background: Fever, decreased sleep time, pain and local reaction are adverseevent following vaccination especially DTwP vaccine. Parent and also medicalstaff almost give paracetamol prophylactic to reduce adverse event aftervaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry ofHealth Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed ornot prophylactic administration of paracetamol post immunization.Objective: To asses the efficacy of prophylactic administration of paracetamolcompared with placebo for prevent adverse event after immunization.Meth0d: A randomized double-blind clinical trials by adminisert paracetamol andplacebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati districtprimary health care and Batu Ampar sub-distric primary health care duringSeptember 2015 to October 2015. One day after vaccination , the treatment groupwas given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while thecontrol group was given placebo . Axillary temperature , time of sleep , and localreactions was evaluated until 4 day after vaccination.Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50with placebo) after DTwP-Hep B-Hib third primary immunization. The baselinecharacteristic including age, gender, and nutritional status were similar in bothgroups . All subject showed no fever, no local reaction, and no sleep disturbance.Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showeda decrease in temperature of 0.1 OC - 0.2 OC (p<0.05) in the first 24 hours postimmunization.Administration of paracetamol showed longer sleep time (p> 0.05)in the first 24 hours post- immunization. |
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