Diclofenactramadol vs.

diclofenac
acetaminophen combinations for pain
relief after caesarean section

Abstract
Latar belakang :
untuk membandingkan efektifitas
kombinasi diclofenacacetaminophen dengan kombinasi
diclofenactramadol sebagai analgesik sesudah operasi
pada tindakan caesarean section
Metode:
randomized,
double-blind,
parallel-group
controlled trial, 204 perempuan yang menjalani
caesarean section diberikan analgesic berupa rectal
suppository diclofenac 100 mg (setiap 8-24 jam)
ditambah
acetaminophen(1
gram/6jam)
atau
tramadol(75 mg/6jam sesudah operasi. Intensitas nyeri
diukur menggunakan numeric rating scale (NRS)

Hasil : secara umum, skor nyeri lebih rendah didapatkan pada kelompok
diclofenac-tramadol. Skor nyeri rendah pada kedua kelompok menunjukkan
kontrol nyeri yang memuaskan pada kedua kelompok. Efek samping yang
didapatkan sedikit kecuali mual yang ditemukan lebih banyak pada kelompok
tramadol dibanding kelompok acetaminophen (15% vs. 2%, P=0.001).
Kesimpulan : Kedua kelompok diklofenak-tramadol dan acetaminophendiclofenac dapat mengontrol nyeri pasca operasi pada wanita yang
menjalani operasi caesar. Kombinasi diklofenak-tramadol secara keseluruhan
lebih efektif tetapi ditemukan insiden mual yang lebih tinggi pasca operasi.

Pendahuluan
Pada pasien pasca operasi diperlukan analgesic yang aman dan juga
efektif
Walaupun telah ditemukan banyak kombinasi analgesic, menemukan
kombinasi yang aman untuk ibu dan bayi yang baru lahir sangat
penting.
Kombinasi yang biasa digunakan di rumah sakit tersebut adalah
diclofenac-tramadol yang dianggap efektif dan mempunyai efek
samping sedikit. Tramadol bekerja sebagai agonis opioid yang lemah
dan penghambat pengambilan kembali monoamin neurotransmitter.
Acetaminophen merupakan salah satu pilihan yang lebih murah.
Bekerja dengan menghambat sintesis prostaglandin dengan
menghambat cyclooxygenase.

Metode
Penelitian ini merupakan randomized, double-blind, parallel- group controlled
trial.
Data dikumpulkan sejak March 2008 dan selesai pada March 2009.
The inclusion criteria were: women aged 1835 years,American Society
ofAnesthesiologists (ASA) status I and II, undergoing caesarean section. The
exclusion criteria were: ASA status III; major co-existing medical illness such
as severe asthma, uncontrolled hypertension or diabetes, liver disease;
peptic ulcer disease or gastrointestinal bleeding; severe pregnancy-induced
hyperten- sion; already on long-term analgesics; at-risk fetus; and known
hypersensitivity to any of the study medications.

All received standard anaesthesia with 2.5 ml of bupivacaine (heavy) 0.5% to

achieve block level up to T4. Diclofenac suppository 100 mg was given at the
end of surgery to both of the groups at 8-hourly interval up to 24 h. For the
index group, intravenous (i.v.) acetaminophen was given at the dose of 1 g
every 6 h, starting from the time of regression of the sensory block to T10.
For the controlgroup,similarprocedurewasfollowedusing i.v. tramadol 75 mg
at 6-hourly intervals. Both the test drugs (tramadol and acetaminophen) were
drawnupinsimilar(Dispovan,Faridabad,Haryana, India) 10 ml coded syringes
and diluted with normal saline so as to make the final volume of injectionto10
ml.Allpatientsreceivedi.v.ondanset- ron 6 mg as a prophylactic anti-emetic
according to hospital protocol.

The primary outcome measure was the summed

painintensitiesduringtheentireobservationperiod, calculated as the
sum of time-weighted pain inten- sity scores as an area under the
curve (AUC). Pain ratings,atrestandonmovement,weremeasuredby
010 numeric rating scale (NRS), during the postoperativeperiodatintervalsof0,1,2,4,8,12and24 h (total of seven time
points of observation). Effective pain control was defined as NRS
scores 3. Pulse, blood pressure (BP) and respiratory rate were also
noted during this time period. Secondary outcome measure was the
use of supplementary rescue anal- gesic (meperidine 30 mg i.v.,
administered if the patients NRS scores 4).

Hasil
The AUC for pain scores across time was significantly lower for the
diclofenactramadol group than forthediclofenacacetaminophen group
(P=0.039). Despite this, the only statistically significant difference between
the two groups emerged at 24 h post- operative with regard to NRS rating of
pain on movement.
There were very few side effects in the acetminophen group: nausea (2%),
dizziness (3%) and headache (3%). Tramadol group experienced rela- tively
more side effects, especially nausea (15%), headache and dizziness (7%
each). Other than the incidence of nausea (P=0.001), these differences were
statistically non-significant.

Pembahasan
This study shows that the diclofenactramadol group was significantly better
than the diclofenacacetaminophen group as regards overall pain control (as
measured by AUC) in women undergoing caesarean section.
Despite this overall main finding, however, our study also found that both
diclofenac acetaminophen and diclofenactramadol combina- tions
effectively controlled pain in this sample. Pain scores, both at rest and on
movement, were in the lower range in both of the groups (NRS pain scores
mostly 3

Side effects of the medications were less in both of the groups. However,
significantly more patients in the tramadol group reported nausea, despite
both groups having received prophylactic ondansetron. The diclofenac
acetaminophen combination was safe during the study period, although
observation over longer term would be needed to confirm this.
Whilehighdosesoftramadolcanbeassociatedwith serious adverse events,
especially seizures, our patients received a total dose of 300 mg in 24 h,
which is lower than the maximum permissible dose (400 mg in 24 h).

Overall,it maybe concluded that both diclofenacacetaminophen and

diclofenactramadol combinations effectively control pain in women
undergoing caesarean section. The diclofenactramadol combi- nation was
overall more efficacious for pain control, but it was also associated with
higher incidence of post-operative nausea. Our results are in line with recent
publications that suggest the efficacy and safety of NSAIDacetaminophen
combination in post-operative pain