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Journal of Clinical Anesthesia (2011) 23, 5357

Original contribution

The efficacy of intravenous paracetamol versus tramadol


for postoperative analgesia after adenotonsillectomy
in children
Hale Yarkan Uysal MD (Specialist in Anesthesiology),
Suna Akin Takmaz MD (Specialist in Anesthesiology),
Ferda Yaman MD (Resident in Anesthesiology),
Blent Baltaci MD (Specialist in Anesthesiology),
Hlya Baar MD (Associate Professor and Head of Department)
Anesthesiology and Reanimation Clinic, The Ministry of Health, Ankara Training and Research Hospital, Ankara, Turkey
Received 29 September 2009; revised 14 May 2010; accepted 3 July 2010

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.

2. Materials and methods


The study protocol was approved by the Institutional
Ethics Commitee of Ankara Training and Research Hospital.
Written, informed consent were obtained from the parents
and from the children over 8 years of age. A total of 66
healthy, ASA physical status I and II children, aged between
6 and 16 years, and scheduled for adenotonsillectomy
operation, were enrolled in the study. Exclusion criteria were
a known history of allergy to the study drugs; active and
severe renal, hepatic, respiratory, or cardiac disease; and
neurological or neuromuscular disorders.
Children were fasted from solid foods for 6 hours before
the procedure; clear liquids were permitted until two hours
prior to surgery. All study patients were premedicated with
oral midazolam 0.5 mg/kg 30 minutes before surgery. In

H.Y. Uysal et al.


the operating room: electrocardiography (ECG), noninvasive blood pressure, and pulse oximetry monitors
were attached. Anesthesia was induced with IV fentanyl
1.0 lg/kg and IV propofol 2.0 to 3.0 mg/kg. Vecuronium
bromide 0.1 mg/kg was given for muscle relaxation. After
tracheal intubation, the lungs were mechanically ventilated
with the pressure-controlled mode (pressure-controlled
ventilation at 15 cm H2O), and end-tidal carbon dioxide
(ETCO 2 ) tension was maintained at 30-35 mmHg.
Intravenous fluid management included administration of
lactated Ringer's solution. Fluid deficit was calculated to be
replaced over three hours, and maintenance fluid was
calculated according to patients' weights.
Anesthesia was maintained with 1.5k to 2.5k sevoflurane
and 50k nitrous oxide in oxygen at a total fresh gas flow of
2.0 L/min. No additional opioids were given intraoperatively.
At the end of the operation, residual neuromuscular block was
reversed with neostigmine 0.04 mg/kg and atropine 0.02 mg/
kg, and the endotracheal tube was removed when respiration
was regular and adequate in rate and depth. Heart rate (HR),
systolic (SBP) and diastolic (DBP) arterial blood pressures,
oxygen saturation (SpO2), and ETCO2 were monitored
continuously during the procedure.
After induction of anesthesia and before the surgical
incision, the children were randomized to one of the two
groups using a computer-generated random numbers table,
with 33 patients in each group. Patients in the paracetamol
group received 15 mg/kg of IV paracetamol (Perfalgan) and
the tramadol group patients received 1.0 mg/kg of IV
tramadol (Tramadolor) over 15 minutes. The medications
were diluted with saline to a total volume of 75 mL. All
study drugs were prepared by an anesthesiologist who was
blinded to the details of the study.
After patient arrival at the PACU, postoperative observational pain scores, emergence agitation, Aldrete scores [12],
HR, and mean arterial blood pressure (MAP) were recorded
every 5 minutes during the first 30 minutes, then every 10
minutes for the remaining 30 minutes of the PACU stay.
Patients were then transferred to the ward. At the ward,
observational pain scores, HR, and MAP were recorded at 2,
3, 4, 5, 6, 8, 12, and 24 hours postoperatively. All
postoperative observations and scores were performed by
the same anesthesiologist who was unaware of the patients'
group assignment.
Pain was assessed using a modification of the pain
score scale originally described by Hannallah et al [13]. This
assess-ment allowed for a maximum score of 10 and a
minimum of 0. This scale has been validated in infants and
children and has been used to score pain after ENT surgery
[3,14]. During the first 6 hours, patients with a pain score of
4 or more received rescue analgesia with IV meperidine 0.5
mg/kg, to a total dose of 1.0 mg/kg until the pain score
was b 4. Thereafter, oral paracetamol 20 mg/kg was
administered every 6 hours. Any patient with a pain score
of 4 or more, in spite of having received oral paracetamol,
received oral ibuprofen 10 mg/kg.

IV paracetamol in children post-tonsillectomy

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.

Table 1 Patient characteristics and duration of anesthesia


and surgery
Variable

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

Data are medians (minimum-maximum) for age and weight, absolute


numbers for gender, and means F SD for duration of anesthesia
and surgery.

Observational Pain Scores

The Pediatric Anesthesia Emergence Delirium (PAED)


Scale devised by Sikich and Lerman was used to assess
emergence agitation [15]. At the same time points, adverse
effects such as PONV, sedation, and rebleeding were
recorded. Nausea was defined as an unpleasant feeling
associated with an inclination to vomit, and vomiting was
defined as the forceful ejection of gastric contents through
the mouth. Sedation was assessed using a 4-point scale,
where 0 = fully awake, 1 = awake but drowsy, 2 = sleeping,
but arousable by light touch or speech, and 3 = sleeping, not
arousable). At the end of the study, parents and ward nurses
were asked to assess the quality of postoperative analgesia
using the following satisfaction scale: 1 = bad, 2 = poor, 3 =
good, 4 = excellent.
A power analysis based on a previous article [16] showed
that a sample size of 20 patients per group was required to
achieve a power of 90k and an a of 0.05 for detection of a
difference of 2 in objective pain scale (OPS) scores between
study groups. All statistical analyses were performed using
SPSS for Windows, version 11.5 (SPSS, Chicago, IL, USA).
Data are shown as means (SD) and medians (minimummaximum) for continuous variables and frequencies with
percentages for categorical variables, respectively. Means

Although 66 children were enrolled in the study, one child


was excluded from the paracetamol group because of
rebleeding that required reoperation one hour after surgery,
and one child was excluded from the tramadol group because
of early discharge to home. Therefore, the number of patients
entered into analysis was 32 in each group.
No statistical differences in age, weight, duration of
surgery, duration of anesthesia (Table 1), or observational
pain scoring at specific time intervals were noted between
the two groups (Fig. 1).
There were also no significant differences between
groups in the number of patients who received rescue
analgesia. Intravenous meperidine was given to 10
(31.25k) paracetamol group patients and to 9 (28.1k)
tramadol group patients (P = 0.784) (Table 2). The mean
time to administration of rescue meperidine analgesia was
10.5 F 6.0 minutes in the paracetamol group and 18.9 F
20.1 minutes in the tramadol group (P = 0.968) (Table 2).
One child receiving IV paracetamol and two children
receiving tramadol needed two doses of meperidine
postoperatively (P = 0.313). At the ward, two children in
the paracetamol group and none in the tramadol group
received oral ibuprofen (P = 0.492).
Eighteen (56.2k) patients in the paracetamol group had an
Aldrete score of 10 at admission to the PACU compared with
16 (50k) in the tramadol group (P = 0.616) (Table 2). The
median Aldrete scores at PACU admission were 10 (6-10) in
the paracetamol group and 10 (8-10) in the tramadol group
(P N 0.05) (Table 2). The mean (SD) time to reach an Aldrete
score of 10 was 10.6 F 17.8 minutes in the paracetamol group
and 18.1 F 22.6 minutes in the tramadol group (P = 0.444)

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

H.Y. Uysal et al.

Table 2 Recovery and analgesic requirements in the


study groups
Variable

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

Data are medians (minimum-maximum), means F SD, or absolute


numbers of patients (k).
PACU = Postanesthesia Care Unit.

(Table 2). The two groups were comparable regarding


emergence agitation scores at the PACU.
Sedation scores did not change significantly over the
course of the assessment period in any group (P = 0.270). No
differences in mean HR or MAP were noted between the two
groups during the study period (P N 0.05).
The frequency of nausea was not significantly different
between the two groups (22k in the paracetamol group and
38k in the tramadol group) (P = 0.171). Postoperative
vomiting occurred in 19k of paracetamol group patients and
34k of tramadol group patients (P = 0.157).
Parents' and nurses' satisfaction scores regarding the
quality of pain management were similar in both groups (P =
0.779, P = 0.385) (Table 3 and Table 4).

4. Discussion
The analgesic efficacy of IV paracetamol 15 mg/kg and
tramadol 1.0 mg/kg in children undergoing adenotonsillectTable 3

Parent satisfaction scores.

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

Data are absolute numbers of patients (k).


1 = bad, 2 = good, 3 = very good, 4 = excellent.

Table 4

Nurse satisfaction scores

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)

Data are absolute numbers of patients (k).


1 = bad, 2 = good, 3 = very good, 4 = excellent.

omy was evaluated, and no statistical difference was found


between groups regarding postoperative pain scores, rescue
analgesic consumption, or PONV. We also failed to show a
significant difference in recovery characteristics between
the groups.
There are conflicting results about the efficacy of IV
paracetamol for postoperative analgesia after tonsillectomy
in children. According to Pendeville et al, IV proparacetamol
30 mg/kg resulted in higher postoperative pain scores than
did IV tramadol 3.0 mg/kg given before surgical incision
[17]. Administration of high doses of tramadol 3.0 mg/kg
may have contributed to the pronounced low postoperative
pain scores in their study. However, in another study,
Alhashemi and Daghistani reported that IV paracetamol 15
mg/kg was an efficient analgesic similar to intramuscular
(IM) meperidine 1.0 mg/kg for children undergoing
tonsillectomy [18].
Evaluation of recovery characteristics and rescue analgesic medication were the other objectives of our study.
Alhashemi and Daghistani found earlier readiness for
recovery room discharge in pediatric patients undergoing
dental restoration with IV paracetamol when compared with
IM meperidine [16]. Similarly, in the present study, although
statistically no difference was detected in recovery characteristics of both drugs, the mean (SD) time to reach an Aldrete
score of 10 in the PACU was shorter in the paracetamol group
(10.6 F 17.8 min vs. 18.1 F 22.6 min in the tramadol group).
Early readiness for PACU discharge was clinically, not
statistically, different in this study, suggesting that IV
paracetamol may offer the advantage of early recovery and
early discharge from hospital, which leads to beneficial
economic aspects for day-case surgeries in children.
Despite the high number of patients receiving rescue
analgesia, pain scores in both groups were lower over the
course of the assessment period in this study. The meperidine
rescue analgesia may have influenced the subsequent low
pain scores in both groups. These data were in disagreement
with the results of Alhashemi and Daghistani [18], who
reported a high percentage of patients requiring rescue
morphine analgesia in the IV paracetamol group versus the
meperidine group. This may be due to the fact that
meperidine was more effective than tramadol for pain relief
after tonsillectomy in children [19].
Vomiting occurred in 40k to 65k of children after
tonsillectomy due to swallowed blood and oropharyngeal

IV paracetamol in children post-tonsillectomy


irritation [20-22]. Tracheal intubation and use of
opioids and nitrous oxide all have been implicated
as anesthetic factors increasing the rate of PONV
[23]. The administration of tramadol
for
postoperative analgesia also may have an
additive effect on the incidence of PONV [24,25].
In our study, the frequency of PONV was not as
high as has been stated in previous reports. These
data may result in part from the anesthetic regimen
that we used in both groups. Another explanation
for the discrepancy in vomiting data may be the
intraoperative administration of tramadol as an IV
infusion over 15 minutes, which reduces the
frequency of PONV compared with postoperative
administration [5,25].
One limitation of our study was the lack of a true
placebo group. We administered intraoperative
opioid to all patients in the study because we
believed that children in a placebo group would
awaken in pain and require rescue meperidine
analgesia in the early postoperative period, which
would have influenced postoperative pain scores,
agitation scores, and sedation scores.
In conclusion, the postoperative analgesia
and early readiness for discharge from the
PACU provided by IV paracetamol 15 mg/kg was
similar to the outcome with IV tramadol 1.0 mg/kg
in children after adenotonsillectomy.

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Efektivitas Parasetamol Intravena dibandingkan Tramadol


untuk Analgesia Pasca Operasi Setelah Adenotonsilektomi
Pada Anak-anak
Hale Yarkan Uysal MD (Spesialis Anestesiologi ), Suna Akin
Takmaz MD (Spesialis Anestesiologi), Ferda Yaman MD (Resident
Anestesiologi), Blent Baltaci MD (Spesialis Anestesiologi),
Hlya Basar MD (Associate Professor dan Kepala Departemen)
Anestesiologi dan Reanimasi Klinik, Departemen Kesehatan, Ankara Pelatihan dan Penelitian
Rumah Sakit, Ankara, Turki

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

PONV dan kepuasan dari para perawat dan orang


tua dengan obat studi adalah tujuan sekunder
penelitian.
2. Bahan dan metode
Protokol penelitian telah disetujui oleh
Komite Etika Kelembagaan Ankara Pelatihan dan
Penelitian Rumah Sakit. Ditulis, informed
consent diperoleh dari orang tua dan anak-anak
lebih dari 8 tahun. Sebanyak 66 status fisik yang
sehat, ASA I dan II anak, berusia antara 6 dan 16
tahun, dan di jadwalkan untuk operasi
tonsilektomi orang dewasa, yang terdaftar dalam
penelitian ini. Kriteria eksklusi adalah riwayat
diketahui alergi terhadap obat; akut dan kronik
ginjal, hati, pernafasan, atau penyakit jantung;
dan gangguan neurologis atau neuromuscular.
Anak-anak berpuasa dari makanan padat
selama 6 jam sebelum prosedur; cairan bening
diperbolehkan sampai dua jam sebelum operasi.
Semua pasien studi di premedikasi dengan
midazolam oral 0,5 mg / kg 30 menit sebelum
operasi. Di ruang operasi : di pasang
elektrokardiografi (EKG), tekanan darah noninvasif, dan pulse oximetry monitor. Anestesi
diinduksi dengan IV fentanyl 1,0 lg / kg dan
propofol IV 2,0-3,0 mg / kg. Vecuronium
bromide 0,1 mg / kg diberikan untuk relaksasi
otot. Setelah intubasi trakea, paru-paru secara
mekanis berventilasi dengan Cara tekanan yang
dikontrol (tekanan ventilasi-dikontrol pada 15 cm
H2O), dan end-tidal karbon dioksida (ETCO2)
tekanan dipertahankan pada 30-35 mmHg.
Manajemen cairan intravena termasuk pemberian
larutan laktat Ringer. Kekurangan cairan dihitung
harus diganti lebih dari tiga jam, dan cairan
maintenance dihitung menurut berat badan
pasien.
Anestesi dipertahankan dengan 1.5k to 2.5k
sevoflurane dan 50k nitrous oxide dalam oksigen
pada aliran gas segar total 2.0L/min. Tidak ada
opioid tambahan diberikan intraoperatif. Pada
akhir operasi, blok neuromuskular residual
terbalik dengan neostigmin 0,04 mg / kg dan

atropin 0,02 mg / kg, dan tabung endotrakeal di


lepas ketika respirasi teratur dan memadai dalam
laju dan kedalaman. Denyut jantung (HR),
sistolik (SBP) dan diastolik (DBP) tekanan darah
arteri, saturasi oksigen (SpO2), dan ETCO2
dipantau terus menerus selama prosedur.
Setelah induksi anestesi dan sebelum sayatan
bedah, anak-anak secara acak salah satu dari dua
kelompok dengan menggunakan tabel angka acak
yang dibuat dengan komputer, dengan 33 pasien
dalam setiap kelompok. Pasien dalam kelompok
parasetamol menerima 15 mg / kg IV
parasetamol (Perfalgan) dan pasien kelompok
tramadol menerima 1,0 mg / kg IV tramadol
(Tramadolor) lebih dari 15 menit. Obat-obat yang
diencerkan dengan saline untuk total volume 75
mL. Semua obat penelitian yang disiapkan oleh
ahli anestesi untuk rincian penelitian.
Setelah pasien tiba di PACU, observasi skor
nyeri pasca operasi, munculnya agitasi, skor
Aldrete [12], HR, dan rata-rata tekanan darah
arteri (MAP) dicatat setiap 5 menit selama 30
menit pertama, kemudian setiap 10 menit untuk
sisa 30 menit dari kedatangan PACU. Pasien
kemudian dipindahkan ke bangsal. Di bangsal,
skor pengamatan sakit, HR, dan MAP tercatat
pada 2, 3, 4, 5, 6, 8, 12, dan 24 jam pasca
operasi. Semua pengamatan pasca operasi dan
skor dilakukan oleh ahli anestesi yang sama yang
tidak menyadari para pasien kelompok tugas.
Nyeri dinilai menggunakan modifikasi dari
skala skor nyeri awalnya digambarkan oleh
Hannallah et al [13]. Ini pengkajian
diperbolehkan untuk skor maksimum 10 dan
minimum 0. Skala ini telah divalidasi pada bayi
dan anak-anak dan telah digunakan untuk
mencetak rasa sakit setelah operasi THT [3,14].
Selama 6 jam pertama, pasien dengan skor nyeri
dari 4 atau lebih diberikan analgesia dengan IV
meperidin 0,5 mg / kg, dengan dosis total 1,0
mg / kg sampai skor nyeri adalah b 4. Setelah itu,
parasetamol oral 20 mg / kg diberikan setiap 6
jam. Setiap pasien dengan skor nyeri dari 4 atau
lebih, meskipun telah menerima parasetamol

oral, dan juga diberikan ibuprofen oral 10 mg /


kg.

The Pediatric Anestesi Emergence Delirium


(PAED) Scale yang dibuat oleh Sikich dan
Lerman digunakan untuk menilai munculnya
agitasi [15]. Pada titik waktu yang sama, efek
samping seperti PONV, sedasi, dan perdarahan
ulang dicatat. Mual didefinisikan sebagai
perasaan yang tidak menyenangkan terkait
dengan kecenderungan untuk muntah, dan
muntah didefinisikan sebagai ejeksi kuat isi
lambung melalui mulut. Sedasi dinilai
menggunakan skala 4-titik, di mana 0 =
sepenuhnya terjaga, 1 = terjaga tetapi mengantuk,
2 = mengantuk, tapi arousable dengan sentuhan
ringan atau suara, dan 3 = tidur, tidak arousable).
Pada akhir penelitian, orang tua dan perawat
bangsal diminta untuk menilai kualitas analgesia
pascaoperasi menggunakan skala kepuasan
berikut: 1 = sangat buruk, 2 = buruk, 3 = baik, 4 =
sangat baik.
Daya analisis berdasarkan pada artikel
sebelumnya [16] menunjukkan bahwa ukuran
sampel dari 20 pasien per kelompok diperlukan
untuk mencapai kekuatan 90K dan dari 0,05
untuk mendeteksi perbedaan dari 2 di skala nyeri
obyektif (OPS) skor antara kelompok belajar.
Semua analisa statistik dilakukan dengan
menggunakan SPSS for Windows, versi 11.5
(SPSS, Chicago, IL, USA). Data ditampilkan
sebagai sarana (SD) dan median (minimummaksimum) untuk variabel kontinyu dan

frekuensi dengan persentase untuk variabel


kategori, masing-masing. Cara itu dibandingkan
dengan menggunakan uji Mann Whitney U.
koreksi Bonferroni diterapkan untuk semua
perbandingan mungkin. Untuk perbandingan
kategoris, analisis Chi-square atau uji Exact
Fisher digunakan bila sesuai. Sebuah P-nilai
kurang dari 0,05 dianggap signifikan secara
statistik.

Waktu saat awal diberikan analgesik


meperidin adalah 10.5 F 6.0 menit pada
kelompok parasetamol dan 18.9 F 20.1 menit
pada kelompok tramadol (P=0.968) (Tabel 2).
Satu anak diberikan parasetamol IV dan dua anak
yang diberikan tramadol IV membutuhkan dua
dosis meperidin pasca operasi (P=0.313). Di
bangsal, dua anak dalam kelompok parasetamol
dan tidak ada pada kelompok tramadol menerima
ibuprofen oral (P=0.492).

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).

Delapan belas (56,2%) pasien dalam


kelompok parasetamol skor Hadan Alderet dari
10 saat masuk ke PACU dibadingkan dengan 16
(50%) pada kelompok tramadol (P = 0,616). Skor
Aldrete median saat masuk PACU yaitu 10 (6-10)
pada kelompok parasetamol dan 10 (8-10) pada
kelompok tramadol (P=0.767). Nilai rata-rata
waktu untuk mencapai skor Aldrete dari 10
adalah 10.6 F 17,8 menit pada kelompok
parasetamol dan 18.1 F 22,6 menit pada
kelompok tramadol (P=0.444) (Tabel 2).
Kedua kelompok sebanding berdasarkan skor
munculnya agitasi di PACU. Skor sedasi tidak
berubah secara signifikan selama periode
penilaian dalam setiap kelompok (P=0.270).
Tidak ada perbedaan dalam rata-rata HR atau
MAP yang dicatat antara kedua kelompok selama
masa penelitian (P=0.05).
Frekuensi mual tidak berbeda secara
signifikan antara kedua kelompok (22% pada

kelompok parasetamol dan 38% pada kelompok

tramadol) (P=0.171). Muntah pasca operasi


terjadi pada 19% pasien kelompok parasetamol
dan 34% pasien kelompok tramadol (P=0.157).
Skor kepuasan orangtua dan perawat
mengenai kualitas manajemen nyeri adalah
serupa pada kedua kelompok (P=0.779, P=0.385)
(Tabel 3 dan Tabel 4).

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,

Alhashemi dan Daghistani melaporkan bahwa


parasetamol IV 15 mg/kg adalah analgesik yang
efisien mirip dengan meperidin IM 1,0 mg/kg
untuk anak-anak yang menjalani tonsilektomi
[18].
Evaluasi karakteristik pemulihan dan obat
penyelamatan analgesik adalah tujuan lain dari
penelitian kami. Alhashemi dan Daghistani
menemukan kesiapan awal untuk ruang
pemulihan debit pada pasien anak yang menjalani
restorasi gigi dengan IV parasetamol bila
dibandingkan dengan IM meperidine [16].
Demikian pula, dalam penelitian ini, walaupun
secara statistik tidak ada perbedaan terdeteksi
dalam pemulihan karakteristik dari kedua obat,
mean (SD) waktu untuk mencapai skor Aldrete
dari 10 di PACU lebih pendek pada kelompok
parasetamol (10,6 F17.8 min vs 18,1 F22.6 min
pada kelompok tramadol). Kesiapan awal untuk
PACU debit secara klinis, secara statistik tidak,
berbeda dalam penelitian ini, menunjukkan
bahwa parasetamol IV mungkin menawarkan
keuntungan dari pemulihan awal dan boleh
pulang lebih awal dari rumah sakit, yang
mengarah
ke
aspek
ekonomi
yang
menguntungkan untuk operasi sehari-kasus pada
anak-anak.
Meskipun banyaknya pasien yang diberikan
analgetik, skor nyeri pada kedua kelompok lebih
rendah selama periode penelitian dalam
penelitian ini. Pemberian analgetik meperidin
mungkin telah mempengaruhi rendahnya skor
nyeri berikutnya pada kedua kelompok. Data ini
bertentangan dengan hasil Alhashemi dan
Daghistani, yang mendapatkan persentase tinggi
pada pasien yang membutuhkan morfin pada
kelompok parasetamol IV dengan kelompok
meperidin. Ini mungkin disebabkan oleh fakta
bahwa meperidin lebih efektif daripada tramadol
untuk menghilangkan rasa sakit setelah operasi
adenotonsilektomi pada anak-anak [19].
Muntah terjadi pada 40k ke 65k anak setelah
tonsilektomi karena darah tertelan dan iritasi

orofaringeal [20-22]. Intubasi trakea dan


penggunaan opioid dan nitrous oxide semua telah
terlibat sebagai faktor anestesi meningkatkan laju
PONV [23]. Pemberian tramadol untuk analgesia
pascaoperasi juga mungkin memiliki efek aditif
terhadap kejadian PONV [24,25]. Dalam
penelitian kami, frekuensi PONV tidak setinggi
seperti yang telah dinyatakan dalam laporan
sebelumnya. Data ini dapat menyebabkan bagian
dari rejimen obat bius yang kita gunakan pada
kedua kelompok. Penjelasan lain untuk
perbedaan dalam muntah data mungkin
administrasi intraoperatif tramadol sebagai infus
IV selama 15 menit, yang mengurangi frekuensi
PONV dibandingkan dengan pasca operasi
administrasi [5,25].
Salah satu keterbatasan dari penelitian kami
adalah kurangnya kelompok plasebo yang benar.
Kami memberikan opioid intraoperatif untuk
semua pasien dalam penelitian ini karena kami
percaya bahwa anak-anak dalam kelompok
plasebo anak terbangun kesakitan dan
membutuhkan analgesik meperidin pada periode
awal pascaoperasi, yang akan mempengaruhi
skor nyari pascaoperasi, skor agitasi, dan skor
sedasi
Kesimpulannya, Analgesik pascaoperasi dan
kesiapan awal untuk keluar dari PACU yang
diberikan parasetamol IV 15 mg/kg mirip dengan
hasil tramadol IV 1,0 mg/kg pada anak-anak
setelah adenotonsilektomi.
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