Worksheet Critical Appraisal

Jurnal Terapi
Judul Jurnal : The efficacy of intravenous paracetamol versus dipyrone for postoperative
analgesia after day-case lower abdominal surgery in children with spinal
anesthesia: a prospective randomized double-blind placebo-controlled
study
Penulis

: Esra Caliskan, Mesut Sener, Aysu Kocum, Nesrin Bozdogan Ozyilkan,

Semire Serin Ezer dan Anis Aribogan

Journal of BioMed Central Anesthesiology 2013,13:34

Validitas
1a. Apakah alokasi pasien terhadap
terapi/perlakukan dilakukan secara
random?

Ya

Alokasi pasien dilakukan secara

[]

random.
Sixty children scheduled for elective
lower abdominal surgery under spinal

Tidak
[

anesthesia were randomized to receive

either intravenous paracetamol 15
mg/kg, dipyrone 15 mg/kg or isotonic
saline.
Terdapat dalam Abstract bagian
Methods halaman 1.

1b. Apakah randomisasi dilakukan

tersembunyi?

Ya
[ ]

Alokasi pasien dilakukan secara

tersembunyi.
The children were randomized to one

Tidak

1c. Apakah antara subyek penelitian

of three groups according to a pregenerated randomization scheme created

[ ]

by the web site Randomization.com.

Ya

Terdapat dalam Methods halaman 2.

Subjek penelitian dan peneliti tidak

dan peneliti blind terhadap

[]

terapi/perlakukan yang akan

mengetahui pengalokasian kelompok

pasien.

diberikan ?
Tidak
[ ]

All study drugs had been prepared by a

researcher (MS) blinded to the treatment
protocol, and were administered using
identical infusion pumps over 15 min by
another researcher (AK) blinded to the
content of the infusion.

2a. Apakah semua subyek yang ikut

serta dalam penelitian
diperhitungkan dalam hasil/

Terdapat dalam Methods halaman 2.

A total of 60 patients

Ya
[]

kesimpulan? (Apakah
pengamatannya cukup lengkap?)

constituted the study population

(Figure 1). There were no
statistically significant

Tidak
[

differences between the groups

with regard to age, sex, weight,
type of operation, duration of
surgery, or anesthesia (Table
1).

2b. Apakah pengamatan yang

dilakukan cukup panjang?

Ya
[ ]

Tidak
[ ]

Terdapat pada Results halaman 4.

Penelitian dilakukan mulai dari
monitoring intraoperatif , injeksi spinal
sampai pasien dipindahkan dari PICU.
Intraoperative monitoring
consisted of non-invasive blood
pressure measurement,
electrocardiogram, pulse
oximetry, and end-tidal carbon
dioxide measurement using a
nasal adapter. After peripheral
intravenous access had been
obtained, an infusion of 0.45%

NaCl in 5% glucose was

administered at 5 ml/kg/h. All
patients had been premedicated
with intravenous midazolam
0.05 mg/kg before lumbar
puncture and supplemental
oxygen 3 l/min was
administered. Children who
were anxious or felt
uncomfortable after
premedication or during surgery
received further sedation with
intravenous boluses of propofol
0.51.0 mg/kg. Lumbar
puncture was performed with
the children in the lateral
decubitus position with the
midline approach with a 26gauge spinal needle (Atraucan;
Braun, Melsungen, Germany) at
the L45 intervertebral space.
After free flow of CSF was
observed, 0.3 mg/kg 0.5%
hyperbaric bupivacaine was
injected. The extent of sensory
block was tested with a pinprick
method, and the degree of
motor blockade was assessed
using the modified Bromage
scale [6,8].
Intraoperative hemodynamic
data, operation types, duration
of surgery and degree of motor

blockade were recorded. After

surgery, the children were
transferred to the post
anesthesia care unit (PACU),
and the time taken for the block
to recede by two segments was
recorded. The intensity of
postoperative pain at rest was
assessed using a visual analog
scale (VAS) (where 0
represented no pain and 10 the
worst pain ever experienced) at
15 and 30 minutes, and 1 h, 2
h, 4 h and 6 h after surgery. Pain
at rest was the primary
outcome measure.
Terdapat dalam Methods halaman 2.
Sedation levels, and all adverse effects
including hypotension (>20% decrease
in systolic blood pressure from
baseline), bradycardia (heart rate <60
beats/min), respiratory depression, and
nausea or vomiting were recorded and
treated until the child was discharged.
Children were discharged from the
PACU when they were fully awake,
hemodynamically stable, breathing
satisfactorily and able to flex their hips.
The time taken to be ready for PACU
discharge was also recorded.

2c. Apakah subyek dianalisis pada

kelompok di mana subyek tersebut
dikelompokkan dalam randomisasi?

Terdapat dalam Methods halaman 3.

After spinal anesthesia, children in

Ya
[ ]

Group Paracetamol received intravenous

paracetamol (PerfalganBristol-Myers
Squibb GmbH, Mnchen, Germany) 15

Tidak
[

mg/kg premixed with 0.9% NaCl to a

total of 50 ml. Group Dipyrone received
intravenous dipyrone (Adepiron,
Adeka, Istanbul, Turkey) 15 mg/kg
premixed with 0.9% NaCl to a total of
50 ml. The placebo group, received 50
ml 0.9% NaCl intravenously (Figure 1)

3a. Selain perlakuan yang

dieksperimenkan, apakah subyek
diperlakukan sama?

Ya
[ ]

Terdapat dalam Methods halaman 2.

Kedua kelompok mendapat perlakuan
yang sama.
Postoperative pain was treated

Tidak
[

according to the same protocol

in all groups. Intravenous
pethidine 0.25 mg/kg was
administered as rescue
analgesia when VAS exceeded 4
out of
10, until the pain score was less
than 4 or to a total dose of 1
mg/kg.
Terdapat dalam Materials and Method

3b. Apakah kelompok dalam

penelitian sama pada awal
penelitian?

Ya

halaman 4.
A total of 60 patients

[ ]

constituted the study population

Tidak
[

(Figure 1). There were no

statistically significant
differences between the groups

with regard to age, sex, weight,

type of operation, duration of
surgery, or anesthesia (Table
1).
Terdapat pada Results halaman 4.
Importance
1. Berapa besar efek terapi?

Visual analogue scale (VAS) scores were

statistically significant between Group Paracetamol
and theplacebo group after 1 hour (p= 0.030) and
between GroupDipyrone and theplacebogroup after
2 h (p=0.010). There was no statistically significant
difference in pain scores at any other times.
The number of patients who received rescue
analgesia was significantly lower for the
Paracetamol and Dipyrone groups compared with
the placebo group (paracetamol versus placebo,
p=0.037; dipyrone versus placebo,p= 0.020) (Table
2).
Terdapat dalam Result halaman 548

Applicable
1. Apakah pasien yang kita miliki
sangat berbeda dengan pasien
dalam penelitian?

Ya
[

Pasien yang kita miliki tidak berbeda

]

dengan pasien dalam penelitian.

Tidak
[ ]
2. Apakah hasil yang baik dari
penelitian dapat diterapkan dengan
kondisi yang kita miliki?

Ya

Kriteria inklusi dan eksklusi sesuai

[ ]
Tidak
[

3. Apakah semua outcome klinis

yang penting dipertimbangkan (efek
samping yang mungkin timbul)?

dengan kondisi yang kita miliki dan

outcome yang baik dapat diterapkan
dengan kondisi yang kita miliki.

Ya
[]

Semua outcome klinis dipertimbangkan

termasuk efek samping yaitu hipotensi,
depresi pernafasan, dan bradikardi.
Selain itu terjadinya agranulositosis

Tidak
[

juga diperhatikan terkait dengan

pemberian anlgesik.

4. Apakah sudah memahami

Ya

Yang diharapkan dari pasien adalah

harapan dan pilihan pasien?

[]

menghasilkan blok sensorik yang lama,

dengan efek samping minimal dan

5. Apakah intervensi yang akan

diberikan akan memenuhi harapan
pasien? Pasien siap akan
konsekuensinya?

Tidak

kualitas yang sangat baik dari analgesia

spinal.

Ya

Yang diharapkan dari pasien adalah

[ ]
Tidak

pemberian paracetamol intravena atau

dipyrone dapat mengontrol nyeri secara
efektif dan mengurangi pemberian pethidine
pada jam-jam pertama dan kedua post

operasi abdomen bagian bawah pada anakanak. Selain itu, paracetamol sama
efektifnya dengan dipyrone dalam hal untuk
menghilangkan rasa sakit

Simpulan : Dari hasi laporan penelitian, maka dapat disimpulkan bahwa laporan penelitian ini
valid dan dapat diaplikasikan.
Level of evidence : IA
Systematic overview or meta-analysis of high-quality randomized controlled trials
Appropriately designed randomized, controlled trial with adequate power to answer the
question posed by the investigators.
Jurnal ini merupakan penelitian prospektif dengan Randomized Double-Blind Plasebo-Controlled
disertai analisis priori power.