Beruflich Dokumente
Kultur Dokumente
Original contribution
Keywords:
Adennotonsillectomy;
Children;
Paracetamol;
Postoperative analgesia;
Tramadol
Abstract
Study Objective: To evaluate the efficacy and the quality of recovery with intravenous (IV) paracetamol
versus tramadol for postoperative analgesia after adenotonsillectomy in children.
Design: Prospective, randomized, double-blinded clinical trial.
Setting: Operating room and Postanesthesia Care Unit (PACU) of a university-affiliated hospital.
Patients: 64 ASA physical status I and II children, aged 6 to 16 years, scheduled for
adenotonsillectomy. Interventions: All patients were premedicated with oral midazolam 0.5 mg/kg 30
minutes before surgery. Patients were randomized to two groups following induction of general
anesthesia. The paracetamol group (n = 32) received 15 mg/kg of IV paracetamol and the tramadol
group (n = 32) received 1.0 mg/kg of IV tramadol.
Measurements: Modified Hannallah pain scores, emergence agitation, Aldrete scores, sedation scores,
time
to first administration of analgesic, heart rate, and mean arterial blood pressure were recorded for each patien
t. Data were recorded every 5 minutes for the first 30 minutes and every 10 minutes for the remaining
30 minutes in the PACU, then at 2, 3, 4, 5, 6, 8, 12, and 24 hours in the ward. The frequency of
postoperative nausea and vomiting also was noted. Satisfaction of parents and nurses was determined on
a 4-point scale at the end of the study.
Main Results: No significant demographic differences between groups were noted. No
statistically
significant difference was found in postoperative pain scores in either group. Agitation scores, Aldrete score
s, sedation scores, and number of patients who received rescue analgesia and time to administration of
rescue analgesia were similar in both groups.
Conclusions: The IV formulation of paracetamol was associated with similar analgesic properties and
early recovery to that of IV tramadol after adenotonsillectomy in children.
2011 Elsevier Inc. All rights reserved.
Corresponding author. . Eme Bulv., C. Atf Kansu Cad., 11.Sok., 8/7 Balgat, Ankara, Turkey.
E-mail address: haleuysal@gmail.com (H.Y. Uysal).
0952-8180/$ see front matter 2011 Elsevier Inc. All rights reserved.
doi:10.1016/j.jclinane.2010.07.001
54
1. Introduction
Adenotonsillectomy is a common surgical procedure in
children. Nonsteroidal anti-inflammatory drugs (NSAIDs)
are effective in reducing postoperative pain, with a lower risk
of postoperative nausea and vomiting (PONV). However,
they also introduce the possibility of increased bleeding due
to their antiplatelet effect [1,2]. Opioids provide satisfactory
analgesia and better emergence in children undergoing ear,
nose, and throat (ENT) surgery, but prolonged sedation due
to opioid use is one of the reasons for delayed discharge
from the hospital after day-case surgeries [3]. The
efficacy of tramadol in relieving post-tonsillectomy pain
has been well documented [4,5]. Due to its negligible effect
on respiration, tramadol may be preferable to traditional
opioids, but side effects such as PONV occur [2].
Paracetamol is a non-opioid analgesic that is devoid of
these risks. Its analgesic action is assumed to be mediated by
a serotonergic mechanism, and the antipyretic action is via
inhibition of cyclooxygenase-3 in the hypothalamus [6].
Paracetamol also has little antiplatelet activity and does not
affect bleeding time, unlike NSAIDs [7]. Although enteral
formulations of paracetamol are the most commonly used
analgesics for management of pain in children, their
analgesic efficacy is weak after ENT surgery [8,9]. An
intravenous (IV) formulation of paracetamol recently has
become available, and it achieves target plasma concentration more rapidly with reduced variability compared with the
rectal and oral formulations [10,11].
This randomized, double-blind, clinical study was
undertaken to evaluate the effectiveness of IV paracetamol
on postoperative pain and its effect on the quality of recovery
versus IV tramadol in children after adenotonsillectomy.
Comparison of the frequency of PONV and satisfaction of
the nurses and parents with the study drugs were secondary
objectives of the study.
55
were compared using the Mann Whitney U test. The
Bonferroni correction was applied for all possible comparisons. For categorical comparisons, Chi-square analysis or
Fisher's Exact test were used where appropriate. A P-value
less than 0.05 was considered statistically significant.
Paracetamol
Tramadol
group (n = 32) group (n = 32)
P-value
Age (yrs)
Weight (kg)
Gender
(women/men)
Duration of
anesthesia (min)
Duration of
surgery (min)
10 (6-16)
34 (33-58)
15/17
10 (6-15)
35 (33-70)
19/13
0.551
0.443
0.316
55.7 F 17.13
52.3 F 17.27
0.108
44.6 F 16.89
39.3 F 15.59
0.056
3. Results
5
4
3
2
1
0
Time (minutes)
Paracetamol Group
Fig. 1
Tramadol Group
Mean observational pain scores in the two groups throughout the study period.
56
Paracetamol
group (n = 32)
Tramadol
group (n = 32)
P-value
Aldrete score
at PACU
admission
No. of patients
with an Aldrete
score of
10 at PACU
admission (k)
Time to reach an
Aldrete score
of 10 (min)
No. of patients
requiring
rescue
analgesia (k)
Time to first
rescue
analgesia (min)
10 (6-10)
10 (8-10)
0.767
18 (56.2)
16 (50.0)
0.616
10.62 F 17.85
18.12 F 22.6
0.444
10 (31.2)
9 (28.1)
0.784
10.5 F 5.98
18.88 F 20.12
0.968
4. Discussion
The analgesic efficacy of IV paracetamol 15 mg/kg and
tramadol 1.0 mg/kg in children undergoing adenotonsillectTable 3
Satisfaction
scores *
Paracetamol group
(n = 32)
Tramadol group
(n = 32)
P-value
1
2
3
4
0 (0)
4 (12.5)
23 (71.9)
5 (15.6)
0 (0)
3 (9.4)
22 (68.8)
7 (21.9)
0.779
Table 4
Satisfaction
scores *
Paracetamol group
(n = 32)
Tramadol group
(n = 32)
P-value
1
2
3
4
2
9
20
1
0
8
23
1
0.385
(6.3)
(28.1)
(62.5)
(3.1)
(0)
(25)
(71.9)
(3.1)
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Abstrak
Tujuan Penelitian : Untuk mengevaluasi efektivitas dan kualitas pemulihan dengan intravena
(IV) parasetamol dibandingkan tramadol untuk analgesia pasca operasi setelah
adenotonsilektomi pada anak-anak.
Desain: prospective, randomized, double-blinded clinical trial.
Tempat: Ruang Operasi dan Unit Post Anesthesia Care (PACU) dari sebuah rumah sakit
universitas yang berafiliasi.
Pasien: 64 status fisik ASA I dan II anak, usia 6 sampai 16 tahun, dijadwalkan untuk
adenotonsilektomi.
Intervensi: Semua pasien premedikasi dengan midazolam oral 0,5 mg/kg 30 menit sebelum
operasi. Pasien diacak menjadi dua kelompok, setelah induksi anestesi umum. Kelompok
parasetamol (n = 32) menerima 15 mg / kg IV parasetamol dan kelompok tramadol (n = 32)
menerima 1,0 mg / kg IV tramadol.
Pengukuran: Modifikasi Hannallah skor nyeri, munculnya agitasi, skor Aldrete, skor sedasi,
waktu untuk pemberian analgesik pertama, denyut jantung, dan rata-rata tekanan darah arteri
direkam untuk setiap pasien. Data dicatat setiap 5 menit untuk 30 menit pertama dan setiap
10 menit untuk sisa 30 menit di PACU, maka pada 2, 3, 4, 5, 6, 8, 12, dan 24 jam di
lingkungan. Frekuensi mual dan muntah pasca operasi juga dicatat. Kepuasan orang tua dan
perawat ditentukan pada skala 4-titik pada akhir penelitian.
Hasil penelelitian
Kesimpulan: adapun formulasi IV parasetamol yang berhubungan dengan sifat analgesik
yang sama dan pemulihan awal dengan IV tramadol setelah adenotonsilektomi pada anakanak.
Kata kunci: Adennotonsillectomy; anak-anak; parasetamol; Analgesia pasca operasi; tramadol
1. Pendahuluan
Adenotonsilektomi
adalah
prosedur
pembedahan umum pada anak-anak. Obat antiinflamasi non steroid (NSAID) efektif dalam
mengurangi nyeri pasca operasi, dengan
rendahnya risiko mual dan muntah pasca operasi
(PONV). Namun, mereka juga mempunyai efek
kemungkinan peningkatan perdarahan akibat
efek antiplatelet [1,2]. Opioid memberikan
analgesia yang memuaskan dan memberikan
hasil lebih baik pada anak-anak yang menjalani
operasi telinga, hidung, dan tenggorokan (THT),
tetapi sedasi berkepanjangan akibat penggunaan
opioid adalah salah satu alasan untuk menunda
pulang dari rumah sakit setelah sehari operasi
[3]. Efektivitas tramadol dalam mengurangi nyeri
pasca tonsilektomi telah diketahui [4,5]. Karena
efeknya yang dapat diabaikan pada respirasi,
tramadol mungkin lebih baik untuk opioid
tradisional, tetapi memiliki efek samping seperti
PONV [2].
Parasetamol merupakan analgesik non-opioid
yang tidak memiliki resiko. Tindakan analgesik
mempunyai mekanisme kerja serotonergik, dan
tindakan antipiretiknya melalui penghambatan
siklooksigenase-3
di
hipotalamus
[6].
Parasetamol juga memiliki aktivitas antiplatelet
kecil dan tidak mempengaruhi waktu perdarahan,
tidak seperti NSAID [7]. Meskipun formulasi
enteral parasetamol adalah analgesik yang paling
umum digunakan untuk manajemen nyeri pada
anak-anak, khasiat analgesik parasetamol lemah
setelah operasi THT [8,9]. Sebuah intravena (IV)
formulasi parasetamol telah tersedia, dan itu
mencapai sasaran plasma konsentrasi-tion lebih
cepat
dengan
variabilitas
berkurang
dibandingkan dengan formulasi rektal dan oral
[10,11].
Studi klinis secara acak double-blind
dilakukan untuk mengevaluasi efektivitas IV
parasetamol pada nyeri pasca operasi dan
efeknya pada kualitas pemulihan dibandingkan
IV
tramadol
pada
anak-anak
setelah
adenotonsilektomi.
Perbandingan
frekuensi
3. Hasil
Meskipun 66 anak yang terdaftar dalam
penelitian ini, satu anak dikeluarkan dari
kelompok parasetamol karena perdarahan ulang
memerlukan reoperation satu jam setelah operasi,
dan satu anak dikeluarkan dari kelompok
tramadol karena lebih awal pulang ke rumah.
Oleh karena itu, jumlah pasien yang dimasukkan
ke dalam analisis adalah 32 dalam setiap
kelompok.
Tidak ada perbedaan statistik dalam usia,
berat badan, durasi operasi, durasi anestesi (Tabel
1), atau skor nyeri pengamatan pada interval
waktu tertentu yang dicatat antara kedua
kelompok (Gambar 1).
Juga tidak ada perbedaan yang signifikan
antara kelompok-kelompok dalam jumlah pasien
yang mendapatkan analgesik. Meperidin IV
diberikan pada 10 (31.25%) pasien kelompok
parasetamol dan 9 (28.1%) pasien kelompok
tramadol (p=0.784) (Table 2).
4. Diskusi
Evaluasi efektivitas analgesik parasetamol IV
15 mg/kg dan tramadol IV 1,0 mg/kg pada anakanak yang menjalani adenotonsilektomi, dan
tidak ada perbedaan statistik yang ditemukan
antara kelompok mengenai skor nyeri
pascaoperasi, pemberian analgesik, atau PONV.
Kami juga gagal untuk menunjukkan perbedaan
yang signifikan dalam karakteristik pemulihan
antara kelompok.
Terdapat hasil yang tidak berhubungan
tentang efektivitas parasetamol IV untuk
analgesik pascaoperasi setelah tonsilektomi pada
anak-anak. Menurut Pendeville et al, parasetamol
pro IV 30mg/kg menghasilkan skor nyeri
pascaoperasi lebih tinggi dari tramadol IV
3,0mg/kg diberikan sebelum sayatan bedah.
Pemberian dosis tinggi tramadol 3,0 mg/kg
mungkin telah memberi kontribusi pada skor
nyeri pascaoperasi jelas rendah dalam penelitian
mereka. Namun, dalam penelitian lain,
[2]
[3]
[4]
[5]
[6]