"
ABSTRAK Latar belakang: Demam, pengurangan waktu tidur, nyeri dan reaksi lokal adalah
beberapa kejadian ikutan pasca imunisasi. Untuk mencegah hal tersebut baik
tenaga medis maupun orang tua memberikan profilaksis parasetamol pasca
imunisasi. Peraturam Menteri Kesehatan Republik Indonesia dan Pedoman
Imunisasi IDAI belum menetapkan secara tegas boleh atau tidaknya pemberian
profilaksis parasetamol pasca imunisasi.
Tujuan: Mengetahui efektivitas pemberian profilaksis parasetamol oral untuk
mencegah 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 imunisasi
kombinasi DTwP-Hep B-Hib di Puskesmas Kecamatan Kramat Jati dan
Puskesmas Kelurahan Batu Ampar selama September 2015 sampai Oktober 2015.
Satu hari pasca imunisasi, kelompok perlakuan diberikan parasetamol (40-50
mg/kgBB/hari), terbagi 4 dosis sedangkan kelompok kontrol, mendapatkan
plasebo. 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 imunisasi
kombinasi DTwP-Hep B-Hib ketiga. Karakteristik dasar meliputi usia, jenis
kelamin, dan status gizi tidak berbeda di kedua kelompok. Subjek penelitian
mendapatkan profilaksis parasetamol (50 subjek) dan profilaksis plasebo (50
subjek). Seluruh subjek penelitian tidak demam, tidak mengalami gangguan tidur,
dan tidak ditemukan reaksi lokal. Pemberian parasetamol 24 jam pasca imunisasi
DTwP-Hep B-Hib menunjukkan penurunan suhu 0,1 OC - 0,2 OC yang bermakna
secara statistik (p < 0,05) pada 24 jam pertama pasca imunisasi. Pemberian
parasetamol menunjukkan waktu tidur yang lebih lama namun tidak bermakna
secara statistik (p>0,05) pada lama tidur.
ABSTRACT Background: Fever, decreased sleep time, pain and local reaction are adverse
event following vaccination especially DTwP vaccine. Parent and also medical
staff almost give paracetamol prophylactic to reduce adverse event after
vaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry of
Health Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI
(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed or
not prophylactic administration of paracetamol post immunization.
Objective: To asses the efficacy of prophylactic administration of paracetamol
compared with placebo for prevent adverse event after immunization.
Meth0d: A randomized double-blind clinical trials by adminisert paracetamol and
placebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati district
primary health care and Batu Ampar sub-distric primary health care during
September 2015 to October 2015. One day after vaccination , the treatment group
was given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while the
control group was given placebo . Axillary temperature , time of sleep , and local
reactions was evaluated until 4 day after vaccination.
Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50
with placebo) after DTwP-Hep B-Hib third primary immunization. The baseline
characteristic including age, gender, and nutritional status were similar in both
groups . All subject showed no fever, no local reaction, and no sleep disturbance.
Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showed
a 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 adverse
event following vaccination especially DTwP vaccine. Parent and also medical
staff almost give paracetamol prophylactic to reduce adverse event after
vaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry of
Health Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI
(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed or
not prophylactic administration of paracetamol post immunization.
Objective: To asses the efficacy of prophylactic administration of paracetamol
compared with placebo for prevent adverse event after immunization.
Meth0d: A randomized double-blind clinical trials by adminisert paracetamol and
placebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati district
primary health care and Batu Ampar sub-distric primary health care during
September 2015 to October 2015. One day after vaccination , the treatment group
was given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while the
control group was given placebo . Axillary temperature , time of sleep , and local
reactions was evaluated until 4 day after vaccination.
Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50
with placebo) after DTwP-Hep B-Hib third primary immunization. The baseline
characteristic including age, gender, and nutritional status were similar in both
groups . All subject showed no fever, no local reaction, and no sleep disturbance.
Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showed
a 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 adverse
event following vaccination especially DTwP vaccine. Parent and also medical
staff almost give paracetamol prophylactic to reduce adverse event after
vaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry of
Health Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI
(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed or
not prophylactic administration of paracetamol post immunization.
Objective: To asses the efficacy of prophylactic administration of paracetamol
compared with placebo for prevent adverse event after immunization.
Meth0d: A randomized double-blind clinical trials by adminisert paracetamol and
placebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati district
primary health care and Batu Ampar sub-distric primary health care during
September 2015 to October 2015. One day after vaccination , the treatment group
was given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while the
control group was given placebo . Axillary temperature , time of sleep , and local
reactions was evaluated until 4 day after vaccination.
Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50
with placebo) after DTwP-Hep B-Hib third primary immunization. The baseline
characteristic including age, gender, and nutritional status were similar in both
groups . All subject showed no fever, no local reaction, and no sleep disturbance.
Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showed
a 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 adverse
event following vaccination especially DTwP vaccine. Parent and also medical
staff almost give paracetamol prophylactic to reduce adverse event after
vaccinantion. Peraturam Menteri Kesehatan Republik Indonesia (Ministry of
Health Republic of Indonesia Health Law) and Pedoman Imunisasi IDAI
(Indonesia Pediatric Society Immunization Guideline) never explicitly allowed or
not prophylactic administration of paracetamol post immunization.
Objective: To asses the efficacy of prophylactic administration of paracetamol
compared with placebo for prevent adverse event after immunization.
Meth0d: A randomized double-blind clinical trials by adminisert paracetamol and
placebo in patients post-immunization DTwP - Hep B - Hib in Kramat Jati district
primary health care and Batu Ampar sub-distric primary health care during
September 2015 to October 2015. One day after vaccination , the treatment group
was given paracetamol (40-50 mg/kg/day) , divided into 4 doses , while the
control group was given placebo . Axillary temperature , time of sleep , and local
reactions was evaluated until 4 day after vaccination.
Result: Subjects of this study consisted of 100 infants (50 with paracetamol & 50
with placebo) after DTwP-Hep B-Hib third primary immunization. The baseline
characteristic including age, gender, and nutritional status were similar in both
groups . All subject showed no fever, no local reaction, and no sleep disturbance.
Prophylactic paracetamol 24 hours post DTwP-Hep B-Hib immunization showed
a 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."
